Common use of Participant Responsibilities Clause in Contracts

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 2 contracts

Samples: www.pfizerclinicaltrials.com, www.pfizerclinicaltrials.com

AutoNDA by SimpleDocs

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, including recent (within the past year) or active suicidal thoughts or behaviors, as determined by the study investigator, that which may put your safety at risk or could have an effect on the study results • Optional Japanese participants must You may be eligible to participate if you have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb well controlled hypertension or hyperlipidemia (99 lb if a Japanese participanthigh cholesterol) by either diet or stable doses of 2 or fewer medications • Your body mass index (BMI) must be between: o Part A, B, and C between 30 20 -33 kg/m2 o Japanese participants – 16 – 33 40 kg/m2 • You may be asked to provide documentation of your childbearing status • You must be eligible to be prescribed Saxenda, and willing to self-administer according to the approved label • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not have a personal or family history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia, type 2 (MEN2), or suspected MTC as determined by the study investigator • You mut not have active/current gallbladder disease • You must not have acute pancreatitis or a history of pancreatitis in the 12 months before the screening visit • You must not have a major depressive disorder or other sever psychiatric disorders (for example, schizophrenia or bipolar disorder) within 2 years before the screening visit • You must not have any history of a suicide attempt in your lifetime • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) that are inhibitors or inducers of certain enzymes or proteins within 7 14 days plus 5 half-lives before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose The study investigator or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose staff will review a list of these medications and substances with you o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o Use of certain medications that are unlikely to interfere with the study results may be allowed but the dose of these background medications should stay the same during the study. • You must not have taken any medications, dietary or herbal supplements that are inhibitors sensitive CYP3A, BCRP, P-gp/MDRI, OATP1B, or inducers UGT1A1 and UGT1A4 substrates after Day -1 of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study study. o The study investigator or study staff will review a list of these medications and substances with you • You must have taken a GLP-1R agonist within 90 days before the first dose of Saxenda • You must not have a known intolerance or hypersensitivity to Saxenda or other GLP-1R agonists • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 24 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you • You may drink water freely o while in the CRU • You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 2 contracts

Samples: www.pfizerclinicaltrials.com, www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, , minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose Hormonal methods of birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary medications or herbal supplements substances that are inhibitors or strong inducers of certain enzymes or proteins CYP3A4 (a gene that alters enzyme activity in the body) within 14 28 days or 5 half-lives (which is drug dependent); before of the first dose dose, or at take any time strong inhibitors of CYP3A4 during the study and for at least 4 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam ritonavir, or any of the components of the liquid formulation study drug or ritonavir • You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not use tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day o You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess of psychiatric condition, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before could have an effect on the first dose and while confined to the CRU study results • Please let us know if you or a relative are a study staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 16 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert cannot lie down for 4 hours after each morning dosing with study staff in case of an emergency drug and ritonavir, unless needed for any study procedures • You will be confined to the procedure room for the first 4 hours during after dosing on Day 1 of each continuous cardiac monitoringperiod, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of the pre-dose sample for study drug and ritonavir on Day 1 of each period • Except for one hour before and one hour after dosing • If dosing under fed conditions (Part A)on Day 1 of each period, you must not eat or may drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug and ritonavir • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug and ritonavir o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing in each period • Dinner will be provided about 9-9 – 10 hours after dosing in each period • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed during each study period • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • You must not have evidence of a prothrombic state (condition associated with blood clots) as demonstrated by any of the following (Part A only): o History of DVT, pulmonary embolism (blood clot in the lungs), arterial thrombosis (blood clot in an artery) o Known genetic (inherited from a parent) predisposition based on medical history ▪ The Study Investigator will review these conditions with you o Any abnormalities in clinical lab tests at screening associated with coagulation system abnormalities • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb not have a history of photosensitivity or phototoxicity (99 lb if a Japanese participantskin reactions in response to light) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary medications or herbal supplements substances that are moderate or strong CYP3A4 (a gene that alters enzyme activity in the body) inducers or time-dependent inhibitors or inducers of certain enzymes or proteins within 14 days or plus 5 half-lives (which is drug dependent); before ) of the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not have been vaccinated with a COVID-19 vaccine within 7 days before screening or within 7 days before any study visit in which a safety lab is scheduled • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions had previous exposure to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study drug • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 18 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 23 (Dosing Sequence 1) or 18 (Dosing Sequence 2) days (Part B) starting with check-in o You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours after morning dosing on Day 7, 10 and 14 (Part A only) during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collectedDays 1, 7 and 14 (Part A) or Day 1 of each period (Part B), unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 4 hours before each safety laboratory test and 8 hours before the collection of pre-dose study drug levels and PD biomarker samples (Part A) • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other predosing or eating a high-dose blood samples o Except for 1 hour before and 1 hour after dosing fat breakfast (Part A only), you may drink water freely o B) • You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If morning dosing when an OGTT will be done (Parts A on Day 1, 7, and B), you must not eat or drink anything (except water) for at least 10 hours before 14 if dosing and/or OGTT • If dosing with a standard breakfast under fasting conditions (Part B A) o Except for 1 hour before and C), 1 hour after morning dosing you must not eat or may drink anything (except water) for at least 10 hours before eating breakfast water freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast or Ensure Plus® (or similar protein rich meal) will be provided about 30 or 20 minutes, respectively, before morning dosing o No food or drink, except water, will be allowed for at least 4 hours after dosing • Lunch will be provided about 4–5 4 hours after dosing and at the same time on Day-1, if applicable • Dinner will be provided about 9-10 hours after dosing and at the same time on Day-1, if applicable • An evening snack may be is allowed about 12-13 hours after o When dosing • If it is necessary to split doses and dose twice a dayday (Part A only), the timing of snack will be given about 20 minutes before dosing and should be completely eaten within 10 minutes • You will be given the same meals or snacks may be changed during on Day 1, 7 (same breakfast only), 14, and -1, if applicable (Part A) • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU• You are encouraged to eat your entire meals on Day -1, meals 1, 7, and 14, and evening snacks will be provided at about the same time as when given on dosing days Day - 2, -1 and 13 (Part A) Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary antibiotics or herbal supplements medications or substances that are moderate or strong CYP3A4 (a gene that alters enzyme activity in the body) inducers or time-dependent inhibitors or inducers of certain enzymes or proteins within 14 days or plus 5 half-lives (which is drug dependent); before ) of the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not test positive for COVID-19 at the time of admission to the CRU • You must not be at increased risk, according to the product label, if dosed with moxifloxacin (including, but not limited to participants with a history of myasthenia gravis [a disease of the immune system], tendinitis, or tendon rupture) • You must not have a history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to moxifloxacin or other drugs in the same class o The study investigator or a member of the study staff will review these drugs with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • You must not have a self-reported history or risk factors for QT prolongation or torsades de pointes (for example, organic heart disease [abnormalities of the muscle tissue of the heart], congestive heart failure, hypokalemia [low blood potassium], hypomagnesia [low blood magnesium], inherited long QT syndrome, myocardial ischemia [reduced ability of the heart to pump blood], inherited deafness, family history of heart attack, sudden death, or long QT syndrome) • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 22 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after morning dosing on day 3 of each period, unless needed for any study procedures • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 4 hours before dosing each safety lab test If dosing under fed conditions (Part A), you You must not eat or drink anything for 1 hour before morning dosing on Day 1 and Day 3 of each period, except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you with the morning meal o You must not eat or drink anything (except water) for at least 10 2 hours before after dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast on Day 3 of each period • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided about 30 minutes before morning dosing and should be entirely eaten with 20 minutes • Lunch will be provided about 4–5 4 hours after morning dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 1211-13 hours after dosing morning dosing, about 30 minutes before evening dosing, and should be entirely eaten within 20 minutes If it is necessary to split doses and dose twice a day, the timing of meals or Evening snacks may be changed during allowed • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks • You will be provided at about restricted to drinking room temperature drinks from Day 1 (before baseline ECG) until the same time as when given on dosing days final ECG measurements have been collected in each study period • You must be willing to eat the food offered during the study Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose Hormonal methods of birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary medications or herbal supplements substances that are inhibitors or strong inducers of certain enzymes or proteins CYP3A4 (a gene that alters enzyme activity in the body) within 14 28 days or 5 half-lives (which is drug dependent); before of the first dose or at during the study, or take any time strong inhibitors of CYP3A4 during the study and for at least 4 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam ritonavir, or any of the components of the liquid formulation study drug or ritonavir • You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not use tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day o You must not use tobacco- or nicotine-containing products for 24 hours before dosing. You cannot use these products, including vaping, while in the CRU • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess of psychiatric condition, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before could have an effect on the first dose and while confined to the CRU study results • Please let us know if you or a relative are a study staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 16 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert cannot lie down for 4 hours after each morning dosing with study staff in case of an emergency drug and ritonavir, unless needed for any study procedures • You will be confined to the procedure room for the first 4 hours during after dosing on Day 1 of each continuous cardiac monitoringperiod, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of the pre-dose sample for study drug and ritonavir on Day 1 of each period • Except for one hour before and one hour after dosing • If dosing under fed conditions (Part A)on Day 1 of each period, you must not eat or may drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug and ritonavir • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period and ritonavir o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug and ritonavir o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing in each period • Dinner will be provided about 9-9 – 10 hours after dosing in each period • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed during each study period • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose Hormonal methods of birth control are allowed o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study You must not have taken any medications, dietary medications or herbal supplements substances that are inhibitors or strong inducers of certain enzymes or proteins CYP3A4 (a gene that alters enzyme activity in the body) within 14 28 days or 5 half-lives (which is drug dependent); before of the first dose dose, or at take any time strong inhibitors of CYP3A4 during the study and for at least 4 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study You must not have a history of sensitivity reactions to midazolam ritonavir, or any of the components of the liquid formulation • study drug or ritonavir  You must not have received the COVID-19 vaccine within 7 days before screening or admission to the CRU or be scheduled to be vaccinated at any time while confined to the CRU for the study  You may only participate in one part be asked to provide documentation of this study • your childbearing status  You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor  You must not use tobacco or nicotine containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day  You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test You must not use tobacco have any significant medical or nicotine-containing products in excess of psychiatric condition, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before could have an effect on the first dose and while confined to the CRU • study results  Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions You will need to stay in the CRU for up to 12 20 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after each morning dosing on days when blood samples for with study drug levels are collectedand ritonavir, unless needed for any study procedures You are advised to avoid direct sunlight must not use tobacco- or any high intensity UV light exposure from your nicotine-containing products for 24 hours before the first admission dose and while confined to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of the pre-dose sample for study drug on Day 1 of each period  Except for one hour before and one hour after morning dosing • If dosing under fed conditions (Part A)on Day 1 of each period, you must not eat or may drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • freely  You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits Lunch will be provided about 4–5 4 hours after morning dosing in each period  Dinner will be provided about 9-9 – 10 hours after morning dosing in each period  An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed during • each study period  Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study o You must not have been vaccinated with a live or attenuated (weakened) vaccine or any live viral components within 6 weeks before the first dose or expect to be vaccinated during treatment or during the follow-up period of the study There is no restriction on vaccination for COVID-19 if the vaccine is not live attenuated • You must not have taken any medicationsvisible skin damage or skin condition (such as sunburn, dietary excessively deep tan, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or herbal supplements that are inhibitors other disfigurations) in or inducers around the application site(s) which, in the opinion of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff investigator, will review a list interfere with the evaluation of these medications and substances with you the test site(s) reaction • You must not take any investigational product have a history of or have active AD, eczema or urticaria (drug hives/rash) • You must not have a history of systemic (affecting the entire body) infection requiring hospitalization, injection or vaccineintravenous (IV) therapy, or otherwise judged clinically significant by the study investigator within 30 days 6 months before Day 1 of the first dose of this study • You must not have a history (single episode) of sensitivity reactions to midazolam disseminated (widespread) herpes zoster (shingles) or any disseminated herpes simplex (includes oral and genital), or recurrent (more than 1 episode of) localized dermatomal herpes zoster (shingles in a single location) • You must not have had an acute (comes on quickly and lasts a short time) disease state (for example, nausea, vomiting, fever, or diarrhea) within 7 days of Day 1 of the components study • You must not have any cancers or a history of cancer with the exception of adequately treated or excised (removed) non-cancerous basal or squamous cell skin cancer • You must not have an immediate family member with hereditary (inherited from parents) immunodeficiency (compromised immune system) • You must not have a history of any lymphoproliferative disorders (diseases with uncontrolled production of lymphocytes [a type of white blood cell]) such as Xxxxxxx Xxxx Virus (EBV – causes mononucleosis) related lymphoproliferative disorder, history of lymphoma (cancer of the liquid formulation lymphatic system), history of leukemia (blood cancer) or signs and symptoms suggestive of current lymphatic or lymphoid disease • You may only participate in one part must not have undergone significant trauma or major surgery within 4 weeks of screening • You must not take any investigational drugs within 30 days before the first dose of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day o You must not use tobacco- or nicotine-containing products for 24 hours before the first dose dose. You cannot use these products, including vaping, while in the CRU • You must not have a history of serious adverse reactions or hypersensitivity to any topical drug or known allergy, allergic reactions, or hypersensitivity to the study drugs or any of their components • You must be willing to refrain from shaving, the use of hair removal products or activities, antiperspirants, lotions, skin creams, fragrances or perfumes, or body oils (for example, baby or coconut oil), use of hair products, hair gels and while confined hair oils in the designated treatment areas for 48 hours before admission to the CRU and for the duration of your stay • You must not have any significant medical or psychiatric condition (including recent [within the past year] or active thoughts of suicide or suicidal behaviors), conditions or situations related to COVID-19 pandemic (for example, contact with a positive case, residence, or travel to an area with a high incidence) as determined by the study investigator that may put your safety at risk or could have an effect on the study results • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You will not be allowed to shower within 1 hour before and for 4 hours after each application of study drug or placebo o You are not required to shower or bathe before each application • You may be asked not use any products in the application area(s) while in the CRU • You should avoid touching the application area(s) or wiping the study drug or placebo off the application areas o You should avoid putting your hands in your mouth to wear a device (similar to a wristwatch) that can be used to alert avoid accidental ingestion of the study staff in case of an emergency drug or placebo • You will be confined allowed to participate in light recreational activities during the procedure room study (for the first 4 hours during each continuous cardiac monitoringexample, except to use the bathroom (Part A onlywatching TV or reading) • You cannot lie down are required to wear loose-fitting clothing and avoid activity that may cause the application to be wiped off the skin, or clothing to stick to the application areas for at least 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 morning and wear eye-protective sunglasses evening applications Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 4 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug each safety lab test • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any prescription or nonprescription medications (including over-the-counter medications, medications such as medications for cold colds or allergies, antacids, dietary and herbal supplements, minerals, or vitamins) supplements within 7 days or 5 half-lives (drug dependent), whichever is longer, before the first dose dosing o You must not take any medications or at any time during substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 within 5 half-lives plus 14 days (up to 28 days) before dosing o A member of the study o staff will review a list of these types of medications and substances with you • You must not take hormone replacement therapy (HRT) or hormonal methods of birth control within at least 28 days before the first dose or dosing and at any time during the study ▪ study. Depo-Provera® must be discontinued at least 6 months before the first dose o dosing • Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days or 5 half- lives before the first dose of this study dosing • You must not have been in a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of previous study with this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw drug • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs and cotinine (a byproduct of nicotine) o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and within 3 months of screening. You cannot use these products, including vaping, while confined to in the CRU • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 5 days (Part AGroups 1 – 5) starting with each check-in o Japanese participants will need to stay in the CRU for 12 or 10 days (Groups 6 and 7) starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after study drug dosing unless needed for any study procedures • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything (except water water) for at least 10 4 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before the collection of the pre-dose blood sample for study drug on Day 1 and for at least 4 hours after study drug dosing except for the fed treatments (Groups 5 and 7) o Except for 1 hour before and 1 hour after study drug dosing, you may drink water freely o There will be no water restrictions for fed dosing (Groups 5 and 7) or for rabeprazole dosing • If When dosing under fed conditions (Part AGroups 5 and 7), you must not eat or drink anything except water for will receive a high-fat, high calorie breakfast after an overnight fast of at least 10 hours before eating o Breakfast should be completely within about 20 minutes. Study drug will be given about 10 minutes after completion of breakfast • If dosing when an OGTT Rabeprazole (Groups 6 and 7) will be done (Parts A and B), you must not eat or drink anything (given about 30 minutes before a meal except water) for Day 1 o Rabeprazole will be given after an overnight fast of at least 10 hours on Day 1 o Study drug will be given about 4 hours after rabeprazole dosing ▪ Group 7 will receive a high-fat, high-calorie breakfast about 30 minutes before study drug dosing. Breakfast should be completely eaten within 20 minutes. Study drug will be given about 10 minutes after completion of breakfast • Lunch will be provided about 4 hours after study drug dosing and/or OGTT If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least Dinner will be provided about 9 to 10 hours before eating breakfast after study drug dosing • An evening snack may be allowed • Meals (breakfast, lunch, dinner, and evening snack) will be provided at appropriate times on all other study days • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be is no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study You must not have take HRT or some hormonal methods of birth control within 28 days before the first dose. These may not be taken at any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 halftime during this study. Depo-lives (which is drug dependent); Provera® must be discontinued at least 6 months before the first dose or at any time during the study o The study investigator or study staff will review a list Some hormonal methods of these medications and substances with you • birth control may be allowed  You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study You must not have received a history of sensitivity reactions to midazolam COVID-19 vaccine within 7 days before screening or admission o You must not be vaccinated with a COVID-19 vaccine at any of time during the components of the liquid formulation • study confinement period  You may only participate in one part be asked to provide documentation of this study • your childbearing status  You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for at least 24 hours before the first dose and each dosing. o You must not smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco/nicotine containing products o You cannot use these products, including vaping, while confined to in the CRU  You must not have any significant medical or psychiatric condition, as determined by the study investigator that may put your safety at risk or could have an effect on the study results  Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions You will need to stay in the CRU for up to 12 20 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collectedmorning dosing, unless needed for any study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions You must not eat or drink anything except water for at least 10 hours before the Day 1 morning procedures in each safety laboratory test • period. On Day 1, you will receive breakfast approximately 2 hours before the 1st dose of study drug and ritonavir. You are encouraged to eat breakfast completely. You will receive lunch approximately 8 hours after your breakfast  Except for 30 minutes before and 1 hour after each dose of study drug you may drink room temperature water freely  You must not eat or drink anything except water for at least 10 4 hours before collection of the pre- dose blood sample for study drug and other most safety laboratory tests. Water is allowed during this time  You may only consume room temperature drinks from Day 1 (prior to pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you ECG measurements) until final ECG measurements have been collected in each study period. Hot or cold drinks are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • allowed during this time.  You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will  You must be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary willing to split doses and dose twice a dayeat the food offered during the study, the timing of meals or snacks may be changed during • including increased fiber content (vegetables)  Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medicationstake hormone replacement therapy (HRT), dietary or herbal supplements that are inhibitors or inducers hormonal methods of certain enzymes or proteins birth control within 14 28 days or 5 half-lives (which is drug dependent); before the first dose or dose. These may not be taken at any time during the study study. Depo-Provera® must be discontinued at least 6 months before the first dose • You must not take MAO inhibitors (used to treat depression, anxiety, and headache) within 14 days before the first dose o The study investigator or study staff will review a list these types of these medications and substances with you during the screening process • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have a history of sensitivity reactions received the COVID-19 vaccine within 7 days before dosing or be scheduled to midazolam or be vaccinated at any of time while confined to the components of CRU for the liquid formulation study • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco have any significant medical or nicotine-containing products in excess psychiatric condition, including recent (within the past year) or active thoughts of suicide or suicidal behaviors, as determined by the equivalent of 5 cigarettes study investigator that may put your safety at risk or 2 chews of tobacco per day could have an effect on the study results • You must not use tobacco- have a history of bone marrow suppression • You must not have a history of aplastic anemia or nicotineagranulocytosis • You must not have a history of a seizure disorder • You must not be shown to carry or be positive for XX-containing products X-X*1502 and HLA-A-1302 o These are markers for 24 hours before the first dose and while confined to the CRU carbamazepine-induced SJS • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 18 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before and 4 hours after dosing with study drug and ritonavir in both study periods. You may drink water freely, except for 1 hour before and 1 hour after these doses. If dosing under fed conditions (Part A), you must not eat There are no food or drink anything except water for at least 10 hours before eating breakfast restrictions around carbamazepine dosing. If dosing when an OGTT will be done (Parts A and B), you You must not eat or drink anything (except water) for at least 10 4 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast each safety laboratory tests • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will You must be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed food offered during the study • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

AutoNDA by SimpleDocs

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-follow- up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugsdrug(s), you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have a history may be asked to provide documentation of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not currently smoke, or use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day nicotine products. • You must not use tobacco- or nicotine-containing products for at least 24 hours before the first dose and each dosing. You cannot use these products, including vaping, while confined to in the CRU • You must not have any significant medical or psychiatric condition, as determined by the study investigator that may put your safety at risk or could have an effect on the study results • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 7 days (Part A) starting with for each check-in o Japanese participants will need to stay in the CRU for 12 days dosing period starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collecteddosing, unless needed for any study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test collection of the pre-dose blood sample for study drug and 4 hours after each dose. Water is allowed during this time • You must not eat or drink anything except water for at least 10 4 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o each safety laboratory test. Water is allowed during this time • Except for 1 hour before and 1 hour after dosing (Part A only)each dose, you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first any dose. Red wine is not allowed through the collection of the last blood sample for study drug in each period • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will You must be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed food offered during the study • Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks No breakfast will be provided at about on the same time as when given on day of dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-follow- up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugsdrug(s), you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have take HRT or some hormonal methods of birth control within 28 days before the first dose. These may not be taken at any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 halftime during this study. Depo-lives (which is drug dependent); Provera® must be discontinued at least 6 months before the first dose or at any time during the study o The study investigator or study staff will review a list Some hormonal methods of these medications and substances with you birth control may be allowed • You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You If you have received the COVID-19 vaccine, you must not have a history of sensitivity reactions to midazolam or any completed the series (2 doses), and at least 7 days should have passed from the time of the components 2nd dose to the time of the liquid formulation screening • You may only participate in one part be asked to provide documentation of this study your childbearing status • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of or wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for at least 24 hours before the first dose and each dosing. o You must not smoke more than 5 cigarettes a day or consume an equivalent quantity of tobacco/nicotine containing products o You cannot use these products, including vaping, while confined to in the CRU • You must not have any significant medical or psychiatric condition, as determined by the study investigator that may put your safety at risk or could have an effect on the study results • For the (optional) Japanese group you must have 4 biological Japanese grandparents who were born in Japan • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up 11 to 25 days in a row (Part 1), 12 days in a row (Part A2), and 7 days in a row (Part 3) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert cannot lie down for 4 hours after morning dosing, unless needed for any study staff in case of an emergency procedures • You will be confined to the procedure room for the first about 4 hours during each continuous cardiac heart monitoring, except to use the bathroom (Part A only1) • You canmust not lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or do any high intensity UV light exposure from your first admission to strenuous activities during the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) period of greater than or equal to 50 and wear eye-protective sunglasses monitoring Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test dose/breakfast in Part 1 and Part 3 and at least 7 hours before the morning dose/breakfast in Part 2. Water is allowed during this time o If dosed under fasted conditions (Part 2) no food will be allowed 2 hours prior to and after dosing. • You must not eat or drink anything except water for at least 10 4 hours before collection of most safety laboratory test. Water is allowed during this time • When dosing in the pre- dose blood sample for study drug and other pre-dose blood samples o Except fasted state except for 1 hour before and 1 hour after dosing (Part A only)each dose, you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will You must be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed food offered during the study • Meals (breakfast, lunch, dinner, and evening snackssnack) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must have 4 Japanese grandparents who were born in Japan if you are of Japanese descent • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants You must not have had any significant illness or surgery within 4 Japanese biological grandparents who were born in Japan weeks before dosing o If you vomit within 24 hours of dosing, you will be carefully evaluated for any upcoming illness or disease • You must weigh more not have a clinically significant history of nasal conditions that may affect the administration or the absorption of the nasal spray • You must not have a significant history of seizure disorder other than 110 lb (99 lb if a Japanese participant) single childhood seizure due to a fever Your body mass index (BMI) You must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 not have a history of gallstones or have had your gall bladder removed • You may be asked to provide documentation of your childbearing status • You must not have take any prescription medications, including OATP1B3 (proteins in the liver) inhibitors within 14 days or 5 half-lives (drug dependent) before dosing o A member of the study staff will review a history list of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus these medications with you o Hormone birth control is allowed • You must not take any over the counter medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before dosing • You must not use nasal spray decongestants for at least 14 days before dosing through collection of the first dose last blood sample for study drug • You must not have received a depot injection (injected medication that releases slowly over time) or at an implant of any time during the study o drug within 3 months before dosing • You must not take hormone replacement therapy (HRT) natural health products, herbal remedies, homeopathic and traditional medicines, probiotics, and food supplements such as vitamins within 28 7 days before dosing through collection of the first dose or at any time during last blood sample for study drug o A member of the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o staff will review a list of these types of products with you • Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary been in a clinical trial with an investigational or herbal supplements that are inhibitors marketed drug product or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) device within 30 days before the first dose of this study dosing • You must not have been in a history clinical trial with a biological product within 90 days of sensitivity reactions to midazolam or any of the components of the liquid formulation dosing You may only participate in one part of this study Your nasal inspections before dosing must be normal • You must not have donated blood for at least 60 days before dosing. Plasma (a component nasal piercings or any physical findings in your nose that, in the opinion of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw the study investigator, would likely interfere with the successful completion of the dosing procedure • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU within 1 month of screening • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 3 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 4 hours before each safety lab test and about 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast in each period • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 4 hours after dosing • Dinner will be provided about 9-9 to 10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) on all other days will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • For the optional Japanese cohort, you must have 4 Japanese grandparents who were born in Japan and • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that which may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb not have a personal or family history of medullary thyroid cancer (99 lb if a Japanese participantMTC) • Your body mass index or multiple endocrine neoplasia type 2 (BMI) must MEN2 – an inherited condition associated with 3 main types of tumors, including MTC), or be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 suspected of having MTC in the judgement of the study investigator • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any prescription or nonprescription medications (including over-the-counter medications, medications such as medications for cold colds or allergies, antacids, dietary and herbal supplements, minerals, or vitamins) within 7 days or 5 half-lives (drug dependent), whichever is longer, before the first dose o You must not take any medications or at any time during substances that are strong inducers or inhibitors of CYP3A4 within 14 days plus 5 half-lives before the first dose o A member of the study o staff will review a list of these types of medications and substances with you • You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during and remain off hormone therapy for the duration of the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugsdrug, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review been in a list of these medications and substances clinical trial with you • You must not take any an investigational product (drug or vaccine) within 30 days or 5 half-lives, whichever is longer, before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose dosing and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 4 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 (Cohorts 1 and 2), or 18 days starting with check-in (Cohort 3) o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after each dose unless needed for study procedures • You will be confined to the procedure room for the first 4 hours after each dose during continuous heart monitoring, except to use the bathroom • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything (except water water) for at least 10 8 hours before each safety laboratory lab test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A)or eating breakfast o Except for 1 hour before and 1 hour after dosing, you must not eat or may drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast freely • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dosedosing. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided if dosing in a fed state • Lunch will be provided about 4–5 4 hours after dosing • Dinner will be provided about 9-9 to 10 hours after dosing • An evening snack may be allowed about 12-13 hours • You may delay or skip meals after dosing • If it is necessary to split doses and dose twice a day, the timing or be offered alternative meals in case of meals nausea or snacks may be changed during vomiting • Meals (breakfast, lunch, dinner, and evening snacks) on all other days will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary or herbal supplements that are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during the study o The study investigator or study staff will review a list of these medications and substances with you • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done to check for such drugs. o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 14 days starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before dosing • If dosing under fed conditions (Part A), you must not eat or drink anything except water for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Lunch will be provided about 4–5 hours after dosing • Dinner will be provided about 9-10 hours after dosing • An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing of meals or snacks may be changed during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) You must not have any significant medical or psychiatric conditionconditions, or COVID-19 related situations (for example, contact with a positive case, residence in, or travel to, an area with a high incidence), as determined by the study investigator, investigator that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study You must not have taken any medications, dietary medications or herbal supplements substances that are strong inducers or inhibitors of CYP3A4 or inducers UGT1A9 (a gene that alters enzyme activity in the body) within 28 days of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or at any time during through 2 days after the study last dose o The study investigator or study staff will review a list of these medications and substances with you  You must not have taken any medications or substances that were highly dependent on UGT1A1 (a gene that provides the body with instructions for making enzymes) during dosing through 5 days after the last dose o The study investigator or study staff will review a list of these medications and substances with you  You must not take any investigational product (drug or vaccine) drugs within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons) of wine, or 1 oz. (2 tablespoons) of hard liquor  You must not use tobacco or nicotine containing products within 3 months of screening or have a positive cotinine urine test  You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). Urine tests will be done throughout the study to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a study staff member of the same sex o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not use tobacco or nicotine-containing products in excess of the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions You will need to stay in the CRU for up to 12 18 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days a row starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You may be asked to wear a device (similar to a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after each dosing on days when blood samples for with study drug levels are collecteddrug, unless needed for any study procedures You are advised should limit your exposure to avoid direct sunlight or any sunlight/high intensity UV ultraviolet light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply and use sunscreen products with a high sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 4 hours before each safety lab test and 10 hours before the collection of each pre-dose sample and 4 hours after each dose. Water is allowed during this time o Except for one hour before and one hour after morning dosing • If dosing under fed conditions (Part A)on Day 1 of each fasted period, you must not eat or may drink anything except water freely  There are no pre-dose water restrictions for at least 10 hours before eating breakfast • If dosing when an OGTT will be done (Parts A and B), you must not eat or drink anything (except water) for at least 10 hours before dosing and/or OGTT • If dosing with a standard breakfast (Part B and C), you must not eat or drink anything (except water) for at least 10 hours before eating breakfast • the fed period  You must not drink red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits  Breakfast will be provided during the fed period about 30 minutes before dosing o Breakfast will not be given during the fasting periods  Lunch will be provided about 4–5 4 hours after study drug dosing in each period  Dinner will be provided about 9-9 – 10 hours after study drug dosing in each period  An evening snack may be allowed about 12-13 hours after dosing • If it is necessary to split doses and dose twice a day, the timing permitted on Day 1 of meals or snacks may be changed during • each study period  Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Participant Responsibilities. You must tell the study investigator if you previously took part in this study, have been in any other study in the past year, or are currently involved in any other study. This includes being in the follow-up visit period of another study • You must agree to the scheduled visits, the study plan, lab tests, study procedures, and diet and activity restrictions (details listed later in this document) • You must not have any significant medical or psychiatric condition, as determined by the study investigator, that may put your safety at risk or could have an effect on the study results • Optional Japanese participants must have 4 Japanese biological grandparents who were born in Japan • You must weigh more than 110 lb (99 lb if a Japanese participant) • Your body mass index (BMI) must be between: o Part A, B, and C – 20 -33 kg/m2 o Japanese participants – 16 – 33 kg/m2 • You may be asked to provide documentation of your childbearing status • You must not have a history of phototoxicity or photosensitivity • You must not have a current or past diagnosis of type 1 or type 2 diabetes mellitus • You must not take any medications (including over-the-counter medications, such as medications for cold or allergies, antacids, herbal supplements, St. John’s Wort, minerals, or vitamins) within 7 days before the first dose or at any time during the study o You must not take hormone replacement therapy (HRT) within 28 days before the first dose or at any time during the study ▪ Depo-Provera® must be discontinued at least 6 months before the first dose o Before taking any drugs other than the study drugs, you must call the CRU for approval. It must first be approved by the study investigator o You must tell the study staff about any drugs taken during the study • You must not have taken any medications, dietary been vaccinated with a COVID-19/flu vaccine within 7 days before screening or herbal supplements that admission or are inhibitors or inducers of certain enzymes or proteins within 14 days or 5 half-lives (which is drug dependent); before the first dose or scheduled for a COVID-19/flu vaccine at any time during your confinement at the study o The study investigator or study staff will review a list CRU • You must test negative for COVID-19 at the time of these medications and substances with you admission to the CRU • You must not take any investigational product (drug or vaccine) within 30 days before the first dose of this study • You must not have a history of sensitivity reactions to midazolam or any of the components of the liquid formulation • You may only participate in one part of this study • You must not have donated blood for at least 60 days before dosing. Plasma (a component of blood) donation may be allowed o You cannot donate any blood or blood products at any time during this study. Donation is not allowed for at least 4 weeks after your last blood draw • You must not have a history of excessive alcohol use or binge drinking and/or other illicit drug use within 6 months before screening o Binge drinking is defined as a pattern of 5 (male) or 4 (female) or more alcoholic drinks in about 2 hours o You should not drink more than 14 alcoholic drinks a week o A drink is defined as 8 oz. (1 cup) of beer, 3 oz. (6 tablespoons1/3 of a cup) of wine, or 1 oz. (2 tablespoons) of hard liquor • You must not be using/taking any drugs of abuse (such as marijuana, cocaine, opioids, etc.). ) o Urine tests will be done to check for such drugs. drugs o If a test is positive, you will not be allowed in the study o Urine collection may be monitored by a A study staff member of the same sex may monitor urine collection o You have the right to refuse to be monitored, but may be disqualified from the study o While in this study, please do not eat anything that contains poppy seeds. They may cause a positive drug test • You must not have hypersensitivity or previous serious/significant adverse events due to antifungal medications in the same family as itraconazole • You must not have any medical conditions, medical history, or are taking any medications that are contraindicated in the itraconazole prescribing information • You must not use tobacco or nicotine-containing products in excess of more than the equivalent of 5 cigarettes or 2 chews of tobacco per day • You must not use tobacco- tobacco or nicotine-containing products for 24 hours before the first dose and while confined to the CRU • Please let us know if you or a relative are a staff member of Pfizer. If so, you may not take part in this study if you or your relative are supervised by the study investigator or are directly involved with the study Activity Restrictions • You will need to stay in the CRU for up to 12 days (Part A) starting with each check-in o Japanese participants will need to stay in the CRU for 12 days overnights, starting with check-in o Participants in Group 4 will need to stay in the CRU for 26 days starting with check-in • You will need to stay in the CRU for 19 days (Part B) • You will need to stay in the CRU for 13 days (Part C) • All participants: you may need to stay in the CRU for longer if you experience a longer study drug effect. This is for safety reasons o The study investigator or study staff will decide when it is safe for you to leave the CRU • You must not do any strenuous exercise for at least 48 hours before each blood draw for safety labs. Examples of this include heavy lifting, weight training, or aerobics o Walking at a normal pace is allowed • You cannot lie down for 4 hours after each dose of study drug (Period 1, Day 1 and Period 2, Day 4), unless needed for any study procedures • You may be asked to wear a device (similar to like a wristwatch) that can be used to alert study staff in case of an emergency • You will be confined to the procedure room for the first 4 hours during each continuous cardiac monitoring, except to use the bathroom (Part A only) • You cannot lie down for 4 hours after dosing on days when blood samples for study drug levels are collected, unless needed for study procedures • You are advised to avoid direct sunlight or any high intensity UV light exposure from your first admission to the CRU through your last follow-up contact with the CRU o You should apply sunscreen with a sun protection factor (SPF) of greater than or equal to 50 and wear eye-protective sunglasses Diet Restrictions • You must not eat or drink anything except water for at least 10 hours before each safety laboratory test • You must not eat or drink anything except water for at least 10 hours before collection of the pre- dose blood sample for study drug and other pre-dose blood samples o Except for 1 hour before and 1 hour after dosing (Part A only), you may drink water freely o You can drink water freely if you are in Part B or C • If dosing under fasting conditions (Part A), you must not eat or drink anything (except water) for at least 10 hours before the dose of study drug on Day 1, Period 1, and the dose of itraconazole on Day 4, Period 2 o Except for 1 hour before and 1 hour after dosing • If dosing under fed conditions (Part A)with the study drug, you may drink water freely • You must not eat or drink anything except water for at least 10 4 hours before eating breakfast each dose of itraconazole when given alone o There are no water restrictions when dosing with itraconazole alone If dosing when an OGTT will be done (Parts A and B), you You must not eat or drink anything (except water) for at least 10 4 hours before dosing and/or OGTT each safety laboratory test If dosing with a standard breakfast (Part B and C), you You must not eat or drink anything (except water) for at least 10 hours before eating breakfast • You must not drink that has red wine for 7 days before the first dose. Red wine is not allowed through the collection of the last blood sample for study drug • You must not eat or drink anything with alcohol for 24 hours (or as stated above for red wine) before (each) check-in. Alcohol is not allowed through the collection of the last blood sample for study drug in each period o Study staff may check your breath for alcohol. If alcohol is found, you will not be allowed in the study • You must not eat or drink anything with caffeine for 24 hours before dosing. Caffeine is not allowed through the collection of the last blood sample for study drug in each period o Caffeine can be found in different foods and drinks. Some examples include chocolate, coffee, tea, cola, Xx. Xxxxxx®, and Mountain Dew® • You must not eat or drink anything that has grapefruit or grapefruit-related citrus fruits for 7 days before the first dose. These are not allowed through collection of the last blood sample for study drug o Examples of citrus fruits that are not allowed are Seville oranges and pomelos o Fruit juices and smoothies may also contain grapefruit or these citrus fruits • Breakfast will be provided about 1 hour after dosing with itraconazole alone, it will not be provided on study drug dosing days (Period 1, Day 1 and Period 2, Day 4) • Lunch will be provided about 4–5 4 hours after dosing the last dose of the morning of either itraconazole or study drug • Dinner will be provided about 9-10 hours after dosing the last dose of the morning of either itraconazole or study drug • An evening snack may be allowed about 12-13 hours after dosing If it is necessary You must be willing to split doses and dose twice a day, eat the timing of meals or snacks may be changed food offered during • Meals (breakfast, lunch, dinner, and evening snacks) will be provided at appropriate times on all other the study days o On non-dosing days while in the CRU, meals and evening snacks will be provided at about the same time as when given on dosing days Possible Benefits of the Study This study is for research purposes only. There may be no direct benefit to you from taking part. However, information learned from this study may benefit other people in the future. Alternatives to Participating in this Study This study is for research purposes only. Your alternative is to not take part in the study.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Time is Money Join Law Insider Premium to draft better contracts faster.