A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants
- Registration Number
- NCT05405543
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 MYK-224 - Arm 1 Placebo - Arm 2 MYK-224 - Arm 2 Placebo - Arm 3 MYK-224 - Arm 3 Placebo - Arm 4 MYK-224 - Arm 4 Placebo -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 Number of participants with adverse events (AEs) Up to 130 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
Trial Locations
- Locations (1)
Local Institution - 0001
🇺🇸Anaheim, California, United States