Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 6 male participants in this part of the study. Length of Study for Participants You will be in this study for about 38 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: 1 dosing period 12 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 6 male participants will be in this part of the study. The dose level of study drug in this cohort will be lower than the highest dose level already evaluated in healthy western participants in Part 1 and Part 2 of the study. Part 1 tested up to 750 mg with ritonavir. Part 2 tested up to 500 mg of study drug with 100 mg ritonavir 2 times a day. Dosing is planned as follows: Group Number Number of Participants Study Treatment Study Days Ritonavir X X X X Study Day -1: Single 100 mg dose of ritonavir given about 12 hours before Day 1 morning dosing with study drug and ritonavir Study Day 1: Single 300 mg dose of study drug given with a single 100 mg dose of ritonavir in the morning; single 100 mg dose of ritonavir given about 12 hours after morning dosing Study Day 2: Single 100 mg dose of ritonavir given about 24 hours after morning dosing on Day 1 The study drug and ritonavir will be given orally (by mouth) as tablets. All doses of ritonavir and study drug will be given with about 8 oz. of water and must be swallowed whole. We will check your mouth after each dose of ritonavir and ritonavir...
Number of Study Participants. PART A There will be up to 32 people joining this part of the study.
Number of Study Participants. [NUMBER OF PARTICIPANTS] Description Frequency/details Per Unit Total for all participants Per Study Participant fee Additional Assessments Screen Failures Unscheduled visits Subject Travel reimbursement Pharmacy Cost Start-up fee Archiving fee Audit fee
Number of Study Participants. This study is being done at about 2 different study sites in 2 countries. There will be up to 60 people in the study, 12 participants in Part 1, up to 30 participants in Part 2 (including 6 Japanese participants if the optional Japanese group is conducted) and a maximum of 18 participants in Part 3 (if done).
Number of Study Participants. There will be about 42 people taking part in this study. Length of Study for Participants You will be in this study for up to about 50 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 3 dosing periods during 1 continuous admission • 22 overnight stays at the 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 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 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 people is not yet known. One group of 42 participants is planned. Dosing is planned as follows: DOSING SEQUENCE NUMBER OF PARTICIPANTS STUDY PERIOD
Number of Study Participants. 183 Statistical Methods
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
Number of Study Participants. There will be about 53 participants taking part in this part of the study. This study is being done at about 4 different study sites in 2 countries. It is expected that about 11 people will take part in this part of the study at this location. This research study may use competitive enrollment. This means that when a certain number of people have entered the research study from all research sites combined, no one else will be allowed to participate. It is possible that you may not be allowed to join the research study.
Number of Study Participants. There will be up to 12 participants taking part in this study. Length of Study for Participants You will be in this study for about 47 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: 5 dosing periods during one continuous admission 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 Eligibility to Participate in Another Drug Study Your eligibility to take part in another study depends on information from this study and previous studies. 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 is currently authorized to treat COVID patients is 300 mg twice a day for 5 days. Dosing in this study is planned as follows: Study Treatment Sequence Number of Participants Study Period Study Treatment A: 300 mg of study drug (two 150 mg tablets, commercial formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment B: 300 mg of study drug (two 150 mg tablets, slower dissolution [slowly dissolves] formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment C: 300 mg of study drug (two 150 tablets, large particle size formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment D: 300 mg of study drug (liquid suspension formulation) with 100 mg of ritonavir (single 100 mg tablet) Study Treatment E: 300 mg of study drug (liquid suspension formulation) The study drug and ritonavir will be given orally (by mouth). The liquid suspension doses that you will receive are compounded in our pharmacy for use in this study. Compounded means that the ingredients are added together and mixed to make the final dose.
