A 2-PART, PHASE 1, OPEN LABEL STUDY WITH A 4-PERIOD, 4-SEQUENCE, CROSSOVER DESIGN IN COHORT 1 AND A 2-PERIOD, 2-SEQUENCE CROSSOVER DESIGN IN COHORT 2 TO COMPARE THE SINGLE DOSE PHARMACOKINETICS OF FIVE DIFFERENT FORMULATIONS OF PF-06882961 ADMINISTERED ORALLY TO OTHERWISE HEALTHY ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY

Registration

Registration

NCT04616339

Study type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Phase

PHASE1

Masking

NONE

Status

COMPLETED

Enrollment

31

Start

2020-11-04

Primary completion

2021-07-19

Lead sponsor

Pfizer

Conditions

Overweight and/or Obesity

Interventions

DRUG:PF-06882961 100 mg

Results posted

FALSE

Individual participant data sharing

NO

Secondary identifiers

EUDRACT_NUMBER:2020-001016-24

Registered primary outcomes

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and B cohort 1 [Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)]
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and B cohort 1 [Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48]
• Maximum Observed Plasma Concentration (Cmax) for Formulations A and B cohort 1 [Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48]
• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for Formulations A and E cohort 2 [Day 1 hour (hr) 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 and end of study (Day 28)]
• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for Formulations A and E cohort 2 [Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48]
• Maximum Observed Plasma Concentration (Cmax) for Formulations A and E cohort 2 [Day 1 hr 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36 and Day 3 hr 48]