A Phase 1 Open-Label, Single-Dose, Two Cohort Crossover Study to Evaluate the Relative Bioavailability of a Test Formulation of PF-07799933 and the Effect of a High-Fat Meal on Plasma Pharmacokinetics of PF-07799933 and PF 07799544 Administered in Combination, and the Impact of a Proton Pump Inhibitor on the Plasma Pharmacokinetics of PF-07799933, in Healthy Participants.
Pfizer
Summary
The purpose of this study is to evaluate the relative bioavailability (rBA) of the Form 2 film-coated tablet of PF-07799933 intended for use in future studies compared to the current Form 1 tablet of PF-07799933 used in Phase 1 studies. Additionally this study will also evaluate the effect of a high-fat meal on the plasma pharmacokinetics (PK), i.e, the rBA compared to overnight fasting, of PF-07799933 and PF-07799544 following concurrent single-dose oral administration of Form 2 film-coated tablet formulation of PF-07799933 with PF-07799544. Finally, this study will also assess the impact of a proton pump inhibitor (a type of acid reducing agent) on PF-07799933 PK of the Form 2 film-coated tablet formulation. These data will be used to inform administration of PF-07799933 and PF-07799544 with food and acid reducing agents in future clinical trials.
Description
This is a Phase 1, open-label, randomized, single-dose, 2-cohort study: a three period two sequence crossover (Relative Bioavailability and Food Effect) cohort in healthy adult participants, and a two-period single sequence cohort (Proton Pump Inhibitor) in healthy adult participants. Cohort 1 of this study, which has 3 periods, will evaluate the impact of the Form 2 film-coated tablet of PF-07799933 (test formulation) compared to the Form 1 tablet of PF-07799933 (reference formulation) used in the C4901001 and C4761001 Phase 1 studies (Period 1 and Period 2). This cohort (Cohort 1) will also…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria * Female participants of non-childbearing potential and male participants 18 to 65 years of age (or the minimum age of consent in accordance with local regulations) at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECGs. * BMI of 16-32 kg/m2; and a total body weight \>50 kg (110 lb) Exclusion Criteria * Evidence or history of clinically significant uveitis, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological…
Interventions
- DrugPF-07799933 tablets with PF-07799544 fasted
Participants receive Form 1 in a single dose of tablet in a single dose combination fasted
- DrugPF-07799933 film-coated tablets with PF-07799544 fasted
Participants receive Form 2 in a single dose of tablet in a single dose combination fasted
- DrugPF-07799933 film-coated tablets with PF-07799544 fed
Participants receive Form 2 in a single dose of tablet in a single dose combination in the fed state
- DrugPF-07799933 film-coated tablets fasted
Participants receive Form 2 in a single dose of tablet fasted
- DrugPF-07799933 film-coated tablets following rabeprazole pretreatment fasted
Participants receive Form 2 in a single dose of tablet following rabeprazole pre-treatment fasted
Location
- Pfizer Clinical Research Unit - New HavenNew Haven, Connecticut