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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: MYK-224
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Arm 2<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Arm 3<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Arm 4<br> | Drug: MYK-224<br>* Specified dose on specified days<br>* Other names: BMS-986435;Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed plasma concentration (Cmax) |  | Up to 72 days | 
| Time of maximum observed concentration (Tmax) |  | Up to 72 days | 
| Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T]) |  | Up to 72 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events (AEs) |  | Up to 130 days | 
| Number of participants with serious adverse events (SAEs) |  | Up to 130 days | 
| Number of participants with adverse events leading to discontinuation |  | Up to 130 days | 
| Number of participants with vital sign abnormalities |  | Up to 72 days | 
| Number of participants with physical exam abnormalities |  | Up to 72 days | 
| Number of participants with clinical laboratory abnormalities |  | Up to 72 days | 
| Number of participants with electrocardiogram (ECG) abnormalities |  | Up to 72 days | 
| Measurement of left ventricular ejection fraction (LVEF) |  | Up to 72 days | 
| Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI) |  | Up to 72 days | 
| Measurement of left ventricular fractional shortening (LVFS) |  | Up to 72 days | 
| Measurement of left ventricular global longitudinal strain (LV GLS) |  | Up to 72 days | 
| Measurement of left ventricle stroke volume (LVSV) |  | Up to 72 days | 
| Measurement of lateral and septal early diastolic mitral annular velocity (e') |  | Up to 72 days | 
| Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e') |  | Up to 72 days | 
| Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio) |  | Up to 72 days | 
| Measurement of left ventricular (LV) mass index |  | Up to 72 days | 
| Measurement of left atrial volume index |  | Up to 72 days | 
| Measurement of interventricular septal thickness |  | Up to 72 days | 
| Measurement of posterior wall thickness |  | Up to 72 days | 
| Measurement of LV end diastolic volume |  | Up to 72 days | 
| Measurement of LV end diastolic volume index |  | Up to 72 days | 
| Measurement of LV end systolic volume |  | Up to 72 days | 
| Measurement of LV end systolic volume index |  | Up to 72 days | 
| Relative bioavailability of test formulation compared to the reference formulation based on Cmax |  | Up to 72 days | 
| Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T) |  | Up to 72 days | 
| Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF) |  | Up to 72 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MYK-224, Healthy Participants of Japanese Ethnicity