A PHASE 1, OPEN-LABEL, RANDOMIZED CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF TWO FORMULATIONS OF PF-07976016 ADMINISTERED ORALLY TO HEALTHY ADULT PARTICIPANTS
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Pfizer
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
Study Overview
Brief Summary
The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
- •Willing to provide consent and follow study requirements
- •Total body weight >110lbs (50kg)
Exclusion Criteria
- •Any condition affecting drug absorption, clinically significant laboratory values
- •HIV, HepB & HepC
- •Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- •Use of prescription or non-prescription drugs within a specified timeframe prior to the first dose of study intervention
- •positive urine drug test at screening/admission
- •History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
- •Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day
Arms & Interventions
Sequence 1
Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.
Intervention: PF-07976016 Formulation A (Drug)
Sequence 1
Participants will receive a single dose of PF-07976016 in up to 3 study periods. In sequence 1, participants will receive formulation A followed by formulation B. There will be 7 days between each dose as a wash out period.
Intervention: PF-07976016 Formulation B (Drug)
Sequence 2
Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.
Intervention: PF-07976016 Formulation A (Drug)
Sequence 2
Participants will receive single doses of PF-07976016 in up to 3 study periods. In sequence 2, participants will receive formulation B followed by formulation A. There will be 7 days between each dose as a wash out period.
Intervention: PF-07976016 Formulation B (Drug)
Outcomes
Primary Outcomes
Area Under the Curve - infinity - AUCinf (as data permit, otherwise AUClast).
Time Frame: Day 1 Hour 0 (pre-dose) through 168 hours post dose in each period
Secondary Outcomes
- Incidence of Treatment Emergent Adverse Events - TEAEs(From first dose (Day 1) up to 28-35 days after final dose; a total of approximately 51 days)