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Effect of BMS-986165 on the Blood Levels of Metformin

NCT ID: NCT04671953

Last Updated: 2021-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-18

Study Completion Date

2021-03-30

Brief Summary

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The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.

Detailed Description

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Conditions

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Healthy Participants

Keywords

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Drug interaction Metformin Pharmacodynamics Pharmacokinetics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1: BMS-986165 Dose 1 + Metformin

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

Metformin

Intervention Type DRUG

Specified dose on specified days

Arm 2: BMS-986165 Dose 2 + Metformin

Group Type EXPERIMENTAL

BMS-986165

Intervention Type DRUG

Specified dose on specified days

Metformin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986165

Specified dose on specified days

Intervention Type DRUG

Metformin

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Deucravacitinib

Eligibility Criteria

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Inclusion Criteria

* Healthy, as determined by having no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, vital signs, and clinical laboratory determinations
* Body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
* Must agree to follow specific methods of contraception, if applicable

Exclusion Criteria

\- Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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PRA Health Sciences - Lenexa

Lenexa, Kansas, United States

Site Status

Countries

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United States

Related Links

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https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

BMS Clinical Trial Information

https://www.bmsstudyconnect.com/s/US/English/USenHome

BMS Clinical Trial Patient Recruiting

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Investigator Inquiry Form

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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IM011-159

Identifier Type: -

Identifier Source: org_study_id