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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

NCT ID: NCT04621227

Last Updated: 2023-12-01

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-15

Study Completion Date

2021-05-13

Brief Summary

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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

Detailed Description

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This study is designed to look at the effect of two doses of PF 06882961 (120 milligram (mg) twice a day (BID) and 200 mg BID) on the levels of one dose of rosuvastatin 10 mg and one dose of midazolam 2 mg, in otherwise healthy, adult participants with obesity. Total duration of study from screening to the telephone visit will be approximately 17 weeks, of which up to 63 days will be inpatient. All subjects take (i) Rosuvastatin alone, Midazolam alone, PF 06882961 alone (120 mg BID), PF 06882961 (120 mg BID) + Rosuvastatin, PF 06882961 (120 mg BID) + Midazolam, PF 06882961 (200 mg BID) alone, PF 06882961 (200 mg BID) + Rosuvastatin, PF 06882961 (200 mg BID)+ Midazolam in the study.

Conditions

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Obesity

Keywords

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obesity

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Crossover
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Period 1

Participants will receive the following treatments in this sequence : (i)Rosuvastatin alone (one dose of 10 mg), (ii) Midazolam alone (one dose of 2mg), (iii) PF 06882961 alone (120 mg twice daily), (iv) PF 06882961 (120 mg twice daily) + Rosuvastatin (one dose of 10mg), (v) PF 06882961 (120 mg) + Midazolam (one dose of 2 mg), (vi) PF 06882961 (200 mg) alone, (vii) PF 06882961 (200 mg) + Rosuvastatin (one dose of 10 mg), (viii) PF 06882961 (200 mg)+ Midazolam (one dose of 2 mg) in the study.

Group Type OTHER

PF-06882961

Intervention Type DRUG

120 mg and 200 mg BID

Rosuvastatin

Intervention Type DRUG

10 mg single dose

Midazolam

Intervention Type DRUG

2mg single dose

Interventions

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PF-06882961

120 mg and 200 mg BID

Intervention Type DRUG

Rosuvastatin

10 mg single dose

Intervention Type DRUG

Midazolam

2mg single dose

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=C3421007

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Other Identifiers

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C3421007

Identifier Type: -

Identifier Source: org_study_id