A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Drug: MYK-224

Study type: Interventional

Funder types: Industry

Identifiers

NCT05405543

CV029-014

Details and patient eligibility

About

The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments
• Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion criteria

• Any acute or chronic medical illness
• History of heart disease

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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36 participants in 4 patient groups

Arm 1

Experimental group

Treatment:

Drug: MYK-224

Other: Placebo

Arm 2

Experimental group

Treatment:

Drug: MYK-224

Other: Placebo

Arm 3

Experimental group

Treatment:

Drug: MYK-224

Other: Placebo

Arm 4

Experimental group

Treatment:

Drug: MYK-224

Other: Placebo