Overview

Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity

Status:
Completed
Trial end date:
2021-05-13
Target enrollment:
0
Participant gender:
All
Summary
A Phase 1 Study To Evaluate The Effect Of Two Steady State Doses of PF 06882961 On Rosuvastatin And Midazolam Pharmacokinetics In Otherwise Healthy Adult Participants With Obesity
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Midazolam
Rosuvastatin Calcium
Criteria
Inclusion Criteria:

- Body Mass Index (BMI) ≥ 30.0 kg/m2 and not more than 45.4 kg/m2 at Screening.

- Stable body weight, defined as <5 kg change (per participant report) for 90 days
before Screening

Exclusion Criteria:

- Known prior participation in a trial involving PF-06882961.

- Known intolerance or hypersensitivity to GLP-1R agonists.

- Known hypersensitivity to rosuvastatin or midazolam.

- Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at
screening. Note: prior diagnoses of gestational diabetes during pregnancy only are
eligible if they meet the other eligibility criteria

- Any lifetime history of a suicide attempt.

- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more
within 60 days prior to dosing.

- Participation in a formal weight reduction program (eg, Weight Watchers) within 90
days prior to Screening.