Clinical trial NCT05405543: A Study to Evaluate the Safety, Tolerability, and Drug Levels of MYK-224 Administered in Single and Multiple Doses in Healthy Adult Japanese Participants
Official title: A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: MYK-224
Healthy Participants of Japanese Ethnicity
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2022-06-06
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 72 days
measure: Time of maximum observed concentration (Tmax)
timeFrame: Up to 72 days
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 72 days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 130 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 130 days
measure: Number of participants with adverse events leading to discontinuation
timeFrame: Up to 130 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 72 days
measure: Number of participants with physical exam abnormalities
timeFrame: Up to 72 days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 72 days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 72 days
measure: Measurement of left ventricular ejection fraction (LVEF)
timeFrame: Up to 72 days
measure: Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)
timeFrame: Up to 72 days
measure: Measurement of left ventricular fractional shortening (LVFS)
timeFrame: Up to 72 days
measure: Measurement of left ventricular global longitudinal strain (LV GLS)
timeFrame: Up to 72 days
measure: Measurement of left ventricle stroke volume (LVSV)
timeFrame: Up to 72 days
measure: Measurement of lateral and septal early diastolic mitral annular velocity (e')
timeFrame: Up to 72 days
measure: Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')
timeFrame: Up to 72 days
measure: Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)
timeFrame: Up to 72 days
measure: Measurement of left ventricular (LV) mass index
timeFrame: Up to 72 days
measure: Measurement of left atrial volume index
timeFrame: Up to 72 days
measure: Measurement of interventricular septal thickness
timeFrame: Up to 72 days
measure: Measurement of posterior wall thickness
timeFrame: Up to 72 days
measure: Measurement of LV end diastolic volume
timeFrame: Up to 72 days
measure: Measurement of LV end diastolic volume index
timeFrame: Up to 72 days
measure: Measurement of LV end systolic volume
timeFrame: Up to 72 days
measure: Measurement of LV end systolic volume index
timeFrame: Up to 72 days
measure: Relative bioavailability of test formulation compared to the reference formulation based on Cmax
timeFrame: Up to 72 days
measure: Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)
timeFrame: Up to 72 days
measure: 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)
timeFrame: Up to 72 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Local Institution - 0001
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: