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A Study to Evaluate the Effect of Food on the Drug Levels of BMS-986196 in Healthy Adult Participants

NCT ID: NCT06034899

Last Updated: 2023-09-21

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

WITHDRAWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2023-11-30

Brief Summary

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The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed \[high-fat meal\]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.

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Detailed Description

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Conditions

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Healthy Adult Volunteers

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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Part 1: BMS-986196 Dose 1 (Treatment A)

Group Type EXPERIMENTAL

BMS-986196

Intervention Type DRUG

Specified dose on specified days

Part 1: BMS-986196 Dose 1 (Treatment B)

Group Type EXPERIMENTAL

BMS-986196

Intervention Type DRUG

Specified dose on specified days

Part 2: BMS-986196 Dose 2 (Treatment A)

Group Type EXPERIMENTAL

BMS-986196

Intervention Type DRUG

Specified dose on specified days

Part 2: BMS-986196 Dose 2 (Treatment B)

Group Type EXPERIMENTAL

BMS-986196

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986196

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
* Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and body weight ≥ 50 kg.
* Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).

Exclusion Criteria

* Any significant acute or chronic medical illness in the assessment of the investigator.
* Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
* Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
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

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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IM038-1014

Identifier Type: -

Identifier Source: org_study_id

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