A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: BMS-986435

Study type: Interventional

Funder types: Industry

Identifiers

NCT06476821

CV029-1010

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese participants.

Enrollment: 20 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening.
• Participants must be Chinese (both biological parents are ethnically Chinese).
• Participant has documented LVEF ≥ 60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion criteria

• Any acute or chronic medical illness.
• Head injury in the last 2 years, intracranial tumor, or aneurysm.
• History of malignancy of any type, except in situ cervical cancer > 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers > 2 years prior to the screening visit.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: BMS-986435

Arm 2

Experimental group

Treatment:

Drug: BMS-986435