Study Summary
This trial will study the effects of MYK-224, given either as a single dose or multiple doses, on healthy adult Japanese participants.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
3 Primary · 26 Secondary · Reporting Duration: Up to 130 days
Up to 130 days
Number of participants with adverse events (AEs)
Number of participants with adverse events leading to discontinuation
Number of participants with serious adverse events (SAEs)
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])
Maximum observed plasma concentration (Cmax)
Measurement of LV end diastolic volume
Measurement of LV end diastolic volume index
Measurement of LV end systolic volume
Measurement of LV end systolic volume index
Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
Measurement of interventricular septal thickness
Measurement of lateral and septal early diastolic mitral annular velocity (e')
Measurement of left atrial volume index
Measurement of left ventricle stroke volume (LVSV)
Measurement of left ventricular (LV) mass index
Measurement of left ventricular ejection fraction (LVEF)
Measurement of left ventricular fractional shortening (LVFS)
Measurement of left ventricular global longitudinal strain (LV GLS)
Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
Measurement of posterior wall thickness
Number of participants with clinical laboratory abnormalities
Number of participants with electrocardiogram (ECG) abnormalities
Number of participants with physical exam abnormalities
Number of participants with vital sign abnormalities
Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)
Relative bioavailability of test formulation compared to the reference formulation based on Cmax
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 of maximum observed concentration (Tmax)
Trial Safety
Safety Progress
Trial Design
4 Treatment Groups
Arm 1
1 of 4
Arm 4
1 of 4
Arm 2
1 of 4
Arm 3
1 of 4
Experimental Treatment
36 Total Participants · 4 Treatment Groups
Primary Treatment: MYK-224 · Has Placebo Group · Phase 1
Arm 1Experimental Group · 2 Interventions: MYK-224, Placebo · Intervention Types: Drug, Other
Arm 4Experimental Group · 2 Interventions: MYK-224, Placebo · Intervention Types: Drug, Other
Arm 2Experimental Group · 2 Interventions: MYK-224, Placebo · Intervention Types: Drug, Other
Arm 3Experimental Group · 2 Interventions: MYK-224, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MYK-224
2022
Completed Phase 1
~90
Trial Logistics
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 130 days
Who is running the clinical trial?
Bristol-Myers SquibbLead Sponsor
2,501 Previous Clinical Trials
3,928,198 Total Patients Enrolled
Eligibility Criteria
Age 18 - 60 · All Participants · 2 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| California | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Local Institution | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments