Number of Study Participants. There will be about 30 participants taking part in this study. You will be in this study for about 45 days. This does not include the time between screening (the period during which your eligibility for participation in this study will be assessed) and dosing, which can be up to 28 days. This study involves: 4 dosing periods during one continuous admission 18 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 There will be at least 5 days between each dose. Your eligibility to take part in another study depends on information from this study and the ongoing 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. The dose of the study drug that will be used to treat people with cancer is not yet known. One group of participants is planned. Dosing in this study is planned as follows: Study Treatment A: 300 mg of study drug (two 125 mg and two 25 mg tablets) IR MST faster dissolution (faster dissolving), fasted (without food) Study Treatment B: 300 mg of study drug (two 125 mg and two 25 mg tablets) IR MST moderate dissolution, fasted Study Treatment C: 300 mg of study drug (four 75 mg tablets) IR DC batch moderate dissolution, fasted Study Treatment D: 300 mg of study drug (four 75 mg tablets) IR DC Continuous (slower dissolution), fasted Study Treatment E: 300 mg of study drug (four 75 mg tablets) IR DC Batch moderate dissolution, fed (with food) An IR (immediate release) formulation releases the active ingredients of a drug in a short period of time. MST (material sparing tablet) means that these tablets were developed on a small scale in order to keep the use of materials low. DC (direct compression) is a manufacturing process. Your study treatment sequence will be randomly assigned, like pulling a number out of a hat. Both you and the study staff will know what you are receiving. The study...
Number of Study Participants. [NUMBER OF PARTICIPANTS] Description Frequency/details Per Unit Total for all participants
Number of Study Participants. There will be about 20 people taking part in this study. You will be in this study for about 75 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 10 dosing periods during one continuous admission 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 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 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. The dose of the study drug that will be used to treat people is not yet known. One group of 20 participants is planned for this study. Dosing for this study is planned as follows:
Number of Study Participants. There will be about 14 people taking part in this study. If possible, 4 of the people 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. You will be in this study for up to about 29 days. This does not include the time between screening and dosing, which can be up to 28 days. This study involves: • 2 dosing periods with a single admission. The admission has 3 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 Your eligibility to take part in another study depends on information from previous studies. 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. The recommended dose of the study drug used to treat people is 10 mg. One group of 14 participants is planned. Participants will be split into two groups of 7 each. Dosing is planned as follows: STUDY GROUP NUMBER OF PARTICIPANTS STUDY PERIOD 1 2
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. 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. 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 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. 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. 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 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.
