NCT05405543
Completed
Phase 1
A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteers
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Maximum observed plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Arm 2
Intervention: Placebo
Arm 3
Intervention: MYK-224
Arm 3
Intervention: Placebo
Arm 4
Intervention: MYK-224
Arm 1
Intervention: MYK-224
Arm 1
Intervention: Placebo
Arm 2
Intervention: MYK-224
Arm 4
Intervention: Placebo
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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 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)
- 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)
Study Sites (1)
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