A Study of How Ibuzatrelvir is Taken up Into the Blood of Healthy Adults After Taking Different Tablets of Ibuzatrelvir
brief summary
Healthy adults will be enrolled into this open-label, Phase 1 research study. Participants will spend about 9 nights and 10 days in the clinical research unit (CRU) and the total time in the study will be about 11 weeks. The goal of this clinical trial is to compare how much of the study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food. The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. This study drug is taken by mouth.
detailed description
This is a Phase 1, open-label, randomized, 4-period, 6-sequence crossover study in healthy adult participants. The goal of this clinical study is to compare how much of the oral (taken by mouth) study drug ibuzatrelvir is in participants' blood after taking one of the two different types of tablets containing the same amount of ibuzatrelvir without food (fasted). The study will also measure how much ibuzatrelvir is in participants' blood after taking one type of the tablets dispersed in water and when one type of the tablets is taken with food. Safety and tolerability after taking the study medication will also be assessed.
Healthy adult participants will be screened within 28 days prior to the first day of study treatment. Participants will take one dose of study drug on the first day of each of 4 dosing periods that are 2-3 days each. Participants will remain in the clinical research unit (CRU) from Day -1 of Period 1 until completion of procedures on Day 3 of Period 4. This means that participants will stay in the CRU for a total of 9 nights and 10 days. The follow-up phone call will take place approximately 28-35 days after the last dose of study drug. The total time in the study is about 10-11 weeks.
The study treatments are:
Treatment A: ibuzatrelvir (original) fasted Treatment B: ibuzatrelvir (new) fasted Treatment C: ibuzatrelvir (new as dispersion in water) fasted Treatment D: ibuzatrelvir (new) fed
This is a crossover study which means that the treatment groups will receive the same treatments (A, B, C, and D) in a different order during the 4 dosing periods.
Group Period 1 Period 2 Period 3 Period 4
1. A (fasted) B (fasted) C (fasted) D (Fed) 2. A (fasted) C (fasted) B (fasted) D (Fed) 3. B (fasted) A (fasted) C (fasted) D (Fed) 4. B (fasted) C (fasted) A (fasted) D (Fed) 5. C (fasted) A (fasted) B (fasted) D (Fed) 6. C (fasted) B (fasted) A (fasted) D (Fed)
During the screening and time in the CRU participants will have:
* Blood and urine samples collected for safety lab tests * Pharmacokinetics (PK) blood samples collected to detect concentrations of ibuzatrelvir (up to 40 samples) * Up to 8 electrocardiograms (ECGs - records the electrical signals controlling your heart) * To fast (not eat) for at least 10 hours overnight before 3 of the 4 doses
official title
A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE-DOSE, 4-PERIOD, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY AND EFFECT OF FOOD FOLLOWING ORAL ADMINISTRATION OF A NEW TABLET FORMULATION RELATIVE TO THE ORIGINAL FORMULATION OF IBUZATRELVIR IN HEALTHY ADULT PARTICIPANTS