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.
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 Approximately 18 participants will be enrolled in the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
18
original
Pfizer Clinical Research Unit - Brussels
Brussels, Bruxelles-capitale, Région de, Belgium
RECRUITINGPlasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast) in the fasted state
Relative bioavailability of a dispersion of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir Cmax in the fasted state
Relative bioavailability of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir Cmax in the fasted state
Relative bioavailability of a dispersion of a new oral formulation of ibuzatrelvir compared to the original tablet formulation in the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Incidence of AEs, clinical laboratory measurements, vital signs, and standard 12-lead ECGs
Evaluate the safety and tolerability of different single-dose oral treatments of ibuzatrelvir
Time frame: Day 1-35
Plasma ibuzatrelvir AUCinf (as data permit, otherwise AUClast)
Relative bioavailability of a new oral formulation of ibuzatrelvir administered in the fed state compared to the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
Plasma ibuzatrelvir Cmax
Relative bioavailability of a new oral formulation of ibuzatrelvir administered in the fed state compared to the fasted state
Time frame: Hour 0 pre-dose in each period and 0.5, 1, 2, 4, 6, 8, 12, 24, and 48 post-dose in each period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.