A Study to Assess the Safety and Tolerability of BMS-986322 in Healthy Participants of Japanese Descent

NCT ID: NCT05546151

Last Updated: 2023-06-22

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-28

Study Completion Date

2023-04-07

Brief Summary

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The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.

Detailed Description

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Conditions

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Healthy Participants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cohort J1

Group Type EXPERIMENTAL

BMS-986322

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986322

Intervention Type OTHER

Specified dose on specified days

Cohort J2

Group Type EXPERIMENTAL

BMS-986322

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986322

Intervention Type OTHER

Specified dose on specified days

Cohort J3

Group Type EXPERIMENTAL

BMS-986322

Intervention Type DRUG

Specified dose on specified days

Placebo for BMS-986322

Intervention Type OTHER

Specified dose on specified days

Interventions

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BMS-986322

Specified dose on specified days

Intervention Type DRUG

Placebo for BMS-986322

Specified dose on specified days

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participant must be of Japanese descent (both biological parents are ethnically Japanese).
* In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
* Women should be of non-childbearing potential.

Exclusion Criteria

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
* Any major surgery within 90 days of study drug administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 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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Anaheim Clinical Trials Llc

Anaheim, California, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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IM032-042

Identifier Type: -

Identifier Source: org_study_id

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