A Study to Evaluate the Drug Levels, Physical and Chemical Changes, and Removal of BMS-986196 in Healthy Male Participants

NCT ID: NCT05981963

Last Updated: 2023-11-13

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

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-17

Study Completion Date

2023-10-22

Brief Summary

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The purpose of this study is to evaluate the excretion pathway of orally administered \[14C\]-BMS-986196 and to assess the safety and tolerability of orally administered BMS-986196.

Detailed Description

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Conditions

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Healthy Male Volunteers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C]-BMS-986196

Group Type EXPERIMENTAL

[14C]-BMS-986196

Intervention Type DRUG

Specified dose on specified days

Interventions

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[14C]-BMS-986196

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986196

Eligibility Criteria

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Inclusion Criteria

* Healthy male participants without clinically significant deviation from normal in medical history, electrocardiogram (ECG), clinical laboratory determinations, and Day -1 physical examination.
* Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m\^2), inclusive, and total body weight ≥ 50 kg

Exclusion Criteria

* Any significant acute or chronic medical illness as determined by the investigator.
* A history of clinically significant hepatic or pancreatic disease.
* Current or recent (within 3 months prior to study treatment administration) gastrointestinal disease that could impact upon the absorption, distribution, metabolism, or excretion of study treatment as determined by the investigator.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

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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Labcorp Clinical Research Unit - Madison

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM038-1007

Identifier Type: -

Identifier Source: org_study_id

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