Common use of Number of Study Participants Clause in Contracts

Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants in this part of the study. Length of Study for Participants You will be in this study for up to about 51 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves:  Up to 4 dosing periods (Periods 3 and 4 are optional) during a continuous admission  Up to 20 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time  1 follow-up phone call about 4 weeks after the last dose of study drug Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that will be used to treat COVID patients is not yet known. One group of up to 12 participants will be in this part of the study. The total daily dose level of study drug in this cohort will not exceed 3,000 mg. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing Periods

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants in about 18 people joining this part of the study. Length of Study for Participants You will be in this study for up to about 51 77 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves:  Up • 1 outpatient run-in period (4 weeks) with 4 outpatient visits to 4 dosing periods (Periods 3 and 4 are optional) during a continuous admission  Up to 20 overnight stays at the Clinical Research Unit (CRU)) • 1 dosing period during 1 continuous admission. 25 overnight stays at CRU. You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose of study drug Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that will be used to treat COVID patients people is not yet known. One group The dose of up to 12 participants study drug in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS Outpatient Inpatient -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 8. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 7 and 9 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 8, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 2½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses will be taken with water. The total daily fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowed. We will check your mouth after each dose level of to make sure the study drug in or placebo have been swallowed This is a research study. The study drug and Saxenda will be given to you only during this cohort study and not after the study is over. Study Process Before any study procedures begin, you will not exceed 3,000 mg. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing Periodsbe asked to read, sign, and date this consent document.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants about 20 people taking part in this part of the study. Length of Study for Participants You will be in this study for up to about 51 75 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves:  Up to 4 • 10 dosing periods (Periods 3 and 4 are optional) during a one continuous admission  Up to 20 o The dose of the study drug will be gradually increased in each period • 44 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time 1 follow-up phone call about 4 weeks after the last dose of study drug Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this studystudy and previous studies. You may be eligible to receive a different study drug in another study as soon early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that will be used to treat COVID patients people is not yet known. One group of up to 12 20 participants will be in is planned for this part of the study. The total daily dose level of Dosing for this study drug in this cohort will not exceed 3,000 mg. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing PeriodsSTUDY PERIOD

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants about 42 people taking part in this part of the study. Length of Study for Participants You will be in this study for up to about 51 50 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves:  Up to 4 • 3 dosing periods (Periods 3 and 4 are optional) during a 1 continuous admission  Up to 20 • 22 overnight stays at the Clinical Research Unit (CRU). You will not be able to leave the CRU during that time 1 follow-up phone call about 4 weeks after the last dose of study drug There will be at least 7 days between the last dose in one period and the first dose in the next period Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from the previous study and this study. You may be eligible to receive a different study drug in another study as soon early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that will be used to treat COVID patients people is not yet known. One group of up to 12 42 participants will be in this part of the study. The total daily dose level of study drug in this cohort will not exceed 3,000 mgis planned. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing PeriodsDOSING SEQUENCE NUMBER OF PARTICIPANTS STUDY PERIOD

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants in about 18 people joining this part of the study. Length of Study for Participants You will be in this study for up to about 51 77 days. This does not include the time between screening and dosing, which can be up to 28 days. This part of the study involves:  Up • 1 outpatient run-in period (4 weeks) with 4 outpatient visits to 4 dosing periods (Periods 3 and 4 are optional) during a continuous admission  Up to 20 overnight stays at the Clinical Research Unit (CRU)) • 1 dosing period during 1 continuous admission. 23 overnight stays at CRU. You will not be able to leave the CRU during that time • 1 follow-up visit to the CRU about 7 days after the last dose • 1 follow-up phone call about 4 weeks after the last dose of study drug Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study. You may be eligible to receive a different study drug in another study as soon as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The dose of the study drug that will be used to treat COVID patients people is not yet known. One group The dose of up to 12 participants study drug in this part of the study will be determined based on information from the previous dosing groups. Dosing is planned as follows: DOSING GROUP NUMBER OF PARTICIPANTS STUDY DAYS Outpatient Inpatient -35 to -29 -28 to -22 -21 to -15 -14 to -8 -7 to -1 1 to 14 1 18 0.6 mg Saxenda 1.2 mg Saxenda 1.8 mg Saxenda 2.4 mg Saxenda 3 mg Saxenda 3 mg Saxenda + TBD* mg study drug or placebo *TBD – to be determined. Dosing for this part of the study will be based on data from the earlier dosing groups. It will be randomly assigned, like the flip of a coin, who receives either study drug or placebo You have about a 1 in 3 chance of being on placebo during the study. On study Day -35, you will visit the CRU for your first injection of Saxenda. It will be given to you by a qualified member of the study staff. Saxenda is given in the abdomen, upper thighs, or upper arms. You will be instructed on how to self-administer Saxenda at home during the 4 week run-in period. You will be given sufficient supplies for dosing at home and instructions about food and beverages relative to the timing of your once daily injections. You will also be instructed on how to store the medication. You will be given a dosing diary to record the dosing time of each dose given at home. You will return to the CRU every week during the outpatient run-in period (Study Days -28, -21, and -14). You will bring your completed dosing diary with you at the time of these visits. During these visits, Saxenda will be administered by the CRU staff and you will be given sufficient supplies for dosing at home. On Study Day -7, you will be admitted to the CRU to continue Saxenda dosing before beginning dosing with study drug or placebo on Study Day 1. Saxenda doses while in the CRU will be given by the study staff, including Day -7 when you check in for the study. You will continue to receive a daily injection of Saxenda through Day -1 of the study. On Day -1 you will fast overnight for at least 10 hours before an OGTT. It will be done at about the same time as scheduled for Day 4. From Days 1 to 14, you will continue to receive Saxenda as a daily injection and you will also receive oral doses of study drug or placebo. On Days 1 – 3 and 5 - 14, you will fast overnight for at least 10 hours before receiving a standard breakfast. Breakfast will be provided about 30 minutes before dosing. It should be completely eaten within 20 minutes. Dosing will take place about 10 minutes after completing breakfast. Saxenda dosing will be within 5 minutes of study drug or placebo dosing. On Day 4, you will fast overnight for at least 10 hours before receiving a single oral dose of study drug or placebo. About 30 minutes after dosing, an OGTT will be done. The timing of the OGTT may be changed based on the study drug blood levels from earlier in the study. An OGTT involves drinking an 8 oz solution containing 75 grams of sugar. It measures how well the body can break down sugar. A blood sample is taken before drinking the solution and approximately 4½ hours after. During this time period, blood samples will be collected approximately every 30 minutes. Both you and the study staff will not know whether you are receiving the study drug or placebo. In case of a medical emergency, the study investigator can find out what you have received if considered necessary. The doses of study drug and placebo that you receive may be compounded in our pharmacy for use in this part of the study. Compounded means that the ingredients are added together and mixed to make the final dose(s). All oral doses will be taken with water. The total daily fluid volume of doses and water will be about 8 oz (1cup). All doses must be completely swallowed. We will check your mouth after each dose level of to make sure the study drug in or placebo have been swallowed This is a research study. The study drug and Saxenda will be given to you only during this cohort study and not after the study is over. Study Process Before any study procedures begin, you will not exceed 3,000 mg. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing Periodsbe asked to read, sign, and date this consent document.

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 12 participants about 14 people taking part in this part study. If possible, 4 of the studypeople will be of Japanese descent. The safety of the study drug and the amount of the study drug in the blood in Japanese participants, if enrolled, will be compared to that of non-Japanese participants. Length of Study for Participants You will be in this study for up to about 51 29 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves:  Up to 4 • 2 dosing periods (Periods with a single admission. The admission has 3 and 4 are optional) during a continuous admission  Up to 20 overnight stays at the Clinical Research research Unit (CRU). You will not be able to leave the CRU during that time 1 follow-up phone call about 4 weeks after the last dose of study drug Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this studyprevious studies. You may be eligible to receive a different study drug in another study as soon early as 30 days after your last dose of study drug in this study. This is true for most drugs. Some drugs may stay in your body longer which means that you may have to wait longer before joining another study. These results are usually known after your last blood sample is tested. We will tell you this as soon as possible. We will also tell you if there is a longer than usual period of time that you should not be in another drug study after this one. Our goal is to keep you from doing anything that might potentially harm you. Dosing Plan The recommended dose of the study drug that will be used to treat COVID patients people is not yet known10 mg. One group of up to 12 14 participants is planned. Participants will be in this part split into two groups of the study. The total daily dose level of study drug in this cohort will not exceed 3,000 mg7 each. Dosing is planned as follows: Dosing Sequence Number of Participants Dosing PeriodsSTUDY GROUP NUMBER OF PARTICIPANTS STUDY PERIOD 1 2 STUDY TREATMENT MICROSAMPLING DEVICE STUDY TREATMENT

Appears in 1 contract

Samples: www.pfizerclinicaltrials.com

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