A Study to Evaluate the Absorption, Metabolism, and Excretion of Orally Administered [14C]-BMS-986368 in Healthy Male Participants

NCT ID: NCT06227975

Last Updated: 2024-05-13

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

2024-02-02

Study Completion Date

2024-04-03

Brief Summary

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The purpose of this study is to investigate the pharmacokinetics (PK), metabolites, route of elimination, and mass balance of BMS-986368 in healthy male participants.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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[14C]-BMS-986368

Group Type EXPERIMENTAL

[14C]-BMS-986368

Intervention Type DRUG

Specified dose on specified days

Interventions

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[14C]-BMS-986368

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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CC-97489

Eligibility Criteria

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Inclusion Criteria

* Healthy male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, 12-lead ECGs, and clinical laboratory determinations, as assessed by the investigator.
* Body mass index of 18.0 to 35.0 kg/m2, inclusive. Body mass index = weight (kg)/(height\[m\])\^2

Exclusion Criteria

* History of hypokalemia.
* Any significant acute or chronic medical illness as determined by the investigator.
* Participant has a history of syncope in the year prior to Day 1.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Celgene

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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Local Institution - 0001

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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IM045-1003

Identifier Type: -

Identifier Source: org_study_id

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