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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental |
| |
| Arm 2 | Experimental |
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| Arm 3 | Experimental |
| |
| Arm 4 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MYK-224 | Drug | Specified dose on specified days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Anaheim | California | 92801 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo | Other | Specified dose on specified days |
|
| 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 |