Healthy Volunteers
Conditions
Keywords
MYK-224, Healthy Participants of Japanese Ethnicity
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.
Interventions
DRUGMYK-224
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | 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
| Measure | 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 ventricular (LV) mass index | 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 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 |
| Measurement of left ventricle stroke volume (LVSV) | Up to 72 days |
| Measurement of left atrial volume index | Up to 72 days |
| Measurement of interventricular septal thickness | Up to 72 days |
Countries
United States
Outcome results
None listed