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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Local Institution - 0001
Anaheim, California, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to 72 days
Time of maximum observed concentration (Tmax)
Time frame: 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])
Time frame: Up to 72 days
Number of participants with adverse events (AEs)
Time frame: Up to 130 days
Number of participants with serious adverse events (SAEs)
Time frame: Up to 130 days
Number of participants with adverse events leading to discontinuation
Time frame: Up to 130 days
Number of participants with vital sign abnormalities
Time frame: Up to 72 days
Number of participants with physical exam abnormalities
Time frame: Up to 72 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 72 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 72 days
Measurement of left ventricular ejection fraction (LVEF)
Time frame: Up to 72 days
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Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Time frame: Up to 72 days
Measurement of left ventricular fractional shortening (LVFS)
Time frame: Up to 72 days
Measurement of left ventricular global longitudinal strain (LV GLS)
Time frame: Up to 72 days
Measurement of left ventricle stroke volume (LVSV)
Time frame: Up to 72 days
Measurement of lateral and septal early diastolic mitral annular velocity (e')
Time frame: Up to 72 days
Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
Time frame: Up to 72 days
Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
Time frame: Up to 72 days
Measurement of left ventricular (LV) mass index
Time frame: Up to 72 days
Measurement of left atrial volume index
Time frame: Up to 72 days
Measurement of interventricular septal thickness
Time frame: Up to 72 days
Measurement of posterior wall thickness
Time frame: Up to 72 days
Measurement of LV end diastolic volume
Time frame: Up to 72 days
Measurement of LV end diastolic volume index
Time frame: Up to 72 days
Measurement of LV end systolic volume
Time frame: Up to 72 days
Measurement of LV end systolic volume index
Time frame: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on Cmax
Time frame: Up to 72 days
Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)
Time frame: 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)
Time frame: Up to 72 days