Trials / Completed
CompletedNCT05677867
A Study to Compare Two Different Forms of PF-07081532 in Adults Who Are Overweight or Obese
A PHASE 1, OPEN-LABEL, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO COMPARE THE SINGLE-DOSE PHARMACOKINETICS OF 2 DIFFERENT FORMULATIONS OF PF-07081532 ADMINISTERED ORALLY TO ADULT PARTICIPANTS WHO ARE OVERWEIGHT OR OBESE
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to compare the amount of PF-07081532 in blood after taking two different forms of PF-07081532. This study is seeking participants who are at least 18 years of age and are overweight and/or obese. All study participants will receive a total of 2 single doses of this study medication in either form. Form A consists of a PF-07081532 20 mg immediate release tablet and a PF-07081532 60 mg immediate release tablet. Form B consists of a PF-07081532 80 mg immediate release tablet. Each single dose will be separated by a minimum of 6 days. The amount of PF-07081532 in the blood for 4 days after taking each single dose will be compared between the two different formulations of PF-07081532. The total time that participants will take part in this study is about 70 days. The first visit is a screening visit to ensure that participants are appropriately qualified for the study. This will occur up to 28 days before the first single dose. Participants will be admitted into the clinic one day prior to the first single dose and will remain in the clinic for a total of 11 days. The study team will phone the participants 28 to 35 days after the last dose of study medication.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Formulation A (PF-07081532 20 mg plus 60 mg) | Formulation A: administered as a 20 mg immediate release tablet and a 60 mg immediate release tablet |
| DRUG | Formulation B (PF-07081532 80 mg) | Formulation B: administered as a 80 mg immediate release tablet |
Timeline
- Start date
- 2023-01-18
- Primary completion
- 2023-03-14
- Completion
- 2023-03-14
- First posted
- 2023-01-10
- Last updated
- 2024-08-09
- Results posted
- 2024-08-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05677867. Inclusion in this directory is not an endorsement.