A Study to Evaluate the Drug Levels of BMS-986166 in Healthy Male Participants

NCT ID: NCT05409157

Last Updated: 2023-03-22

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

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-17

Study Completion Date

2022-10-15

Brief Summary

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The purpose of this study is to assess the drug levels of BMS-986166 in healthy male participants.

Detailed Description

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Conditions

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Healthy Participants

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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Treatment Group 1: BMS-986166

Group Type EXPERIMENTAL

BMS-986166

Intervention Type DRUG

Specified dose on specified days

Bisacodyl

Intervention Type DRUG

Specified dose on specified days

Interventions

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BMS-986166

Specified dose on specified days

Intervention Type DRUG

Bisacodyl

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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Dulcolax®

Eligibility Criteria

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Inclusion Criteria

* Healthy male participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations
* Body mass index between 18.0 to 33.0 kg/m2 (inclusive)

Exclusion Criteria

* Any significant acute or chronic medical illness
* Current or recent history of constipation or irregular bowel movement (less than 1 bowel movement per day within the last 1 week)
* History of allergy (such as rash, hives, breathing difficulties) to any medications, either prescription or nonprescription
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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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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IM018-010

Identifier Type: -

Identifier Source: org_study_id

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