Clinical trial

A PHASE 1, OPEN -LABEL, FIXED SEQUENCE STUDY TO EVALUATE THE EFFECT OF TWO STEADY STATE DOSE LEVELS OF PF-06882961 ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF ROSUVASTATIN AND MIDAZOLAM IN OTHERWISE HEALTHY ADULT PARTICIPANTS WITH OBESITY

Name

C3421007

Description

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

Trial arms

Trial start

2020-12-15

Estimated PCD

2021-05-13

Trial end

2021-05-13

Status

Completed

Phase

Early phase I

Treatment

PF-06882961

120 mg and 200 mg BID

Arms:

Period 1

Rosuvastatin

10 mg single dose

Arms:

Period 1

Midazolam

2mg single dose

Arms:

Period 1

Size

Primary endpoint

Area Under the Plasma Concentration-time Profile From Time 0 to Last Quantifiable Concentration (AUClast) of Rosuvastatin in Periods 1, 4 and 7

At 0 (prior to rosuvastatin dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, and 72 hours post rosuvastatin dose on Day 1 in Periods 1, 4, and 7

AUClast of Midazolam in Periods 2, 5 and 8

At 0 (prior to midazolam dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours post midazolam dose on Day 1 in Periods 2, 5, and 8

Eligibility 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Crossover', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 16, 'type': 'ACTUAL'}}

Updated at

2023-12-01

1 organization

3 products

1 indication

Organization

Product

Indication

Product

Product