NCT04616339

STUDY TO COMPARE PHARMACOKINETICS (PK) OF SINGLE ORAL DOSES OF DIFFERENT PF-06882961 FORMULATIONS IN PARTICIPANTS WHO ARE OVERWEIGHT OR HAVE OBESITY

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the effect of formulation on relative bioavailability of PF-06882961.

Conditions

• Overweight and/or Obesity

Interventions

Type	Name	Description
DRUG	PF-06882961 100 mg	PF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D). Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E)

Timeline

• Start date: 2020-11-04
• Primary completion: 2021-07-19
• Completion: 2021-07-19
• First posted: 2020-11-04
• Last updated: 2022-04-04

Locations

1 site across 1 country: Belgium

Regulatory

• FDA-regulated drug study