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A Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants

NCT ID: NCT05852769

Last Updated: 2023-09-26

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-08-24

Brief Summary

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This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BMS-986196 and/or Cocktail Probe Substrate Drugs

Group Type EXPERIMENTAL

BMS-986196

Intervention Type DRUG

Specified dose on specified days

Caffeine

Intervention Type DRUG

Specified dose on specified days

Montelukast

Intervention Type DRUG

Specified dose on specified days

Flurbiprofen

Intervention Type DRUG

Specified dose on specified days

Omeprazole

Intervention Type DRUG

Specified dose on specified days

Midazolam

Intervention Type DRUG

Specified dose on specified days

Digoxin

Intervention Type DRUG

Specified dose on specified days

Pravastatin

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986196

Specified dose on specified days

Intervention Type DRUG

Caffeine

Specified dose on specified days

Intervention Type DRUG

Montelukast

Specified dose on specified days

Intervention Type DRUG

Flurbiprofen

Specified dose on specified days

Intervention Type DRUG

Omeprazole

Specified dose on specified days

Intervention Type DRUG

Midazolam

Specified dose on specified days

Intervention Type DRUG

Digoxin

Specified dose on specified days

Intervention Type DRUG

Pravastatin

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m\^2), inclusive, and body weight ≥50.0 kg.

Exclusion Criteria

* History of rhabdomyolysis.
* History of peptic ulcer disease or significant GI bleeding.
* History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 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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ICON plc

Millcreek, Utah, 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

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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IM038-022

Identifier Type: -

Identifier Source: org_study_id

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