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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Participants

Treatments: Drug: BMS-986322; Other: Placebo for BMS-986322

Study type: Interventional

Funder types: Industry

Identifiers

NCT05546151

IM032-042

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Other protocol-defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Cohort J1

Experimental group

Treatment:

Other: Placebo for BMS-986322

Drug: BMS-986322

Cohort J2

Experimental group

Treatment:

Other: Placebo for BMS-986322

Drug: BMS-986322

Cohort J3

Experimental group

Treatment:

Other: Placebo for BMS-986322

Drug: BMS-986322