A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants
NCT Number: NCT06476821
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteers
Interventions: DRUG: BMS-986435
Sponsor: Bristol-Myers Squibb
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-27
Completion Date: 2024-09-22
Locations: Zhongshan Hospital Fudan University, Xuhui District, Shanghai, 200032, China

Summary:
The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics following a single oral dose of BMS-986435 in healthy adult Chinese participants.

Primary Outcome Measures: Maximum observed concentration (Cmax), Up to Day 30|Time of maximum observed concentration (Tmax), Up to Day 30|Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)), Up to Day 30
Secondary Outcome Measures: Number of participants with Adverse Events, From date of written consent up to 28 days post last dose|Number of participants with Serious Adverse Events, From date of written consent up to 28 days post last dose|Number of participants with AEs leading to discontinuation, From date of written consent up to 28 days post last dose|Number of participants with vital sign abnormalities, Up to Day 31|Number of participants with electrocardiogram (ECG) abnormalities, Up to Day 31|Number of participants with echocardiogram abnormalities, Up to Day 30|Number of participants with physical examination abnormalities, Up to Day 31|Number of participants with clinical laboratory abnormalities, Up to Day 31|Echocardiographic measures of cardiac systolic function: left ventricular ejection fraction (LVEF), Up to Day 30|Echocardiographic measures of cardiac systolic function: left ventricular outflow tract velocity time integral (LVOT-VTI), Up to Day 30|Echocardiographic measures of cardiac systolic function: left ventricular fractional shortening (LVFS), Up to Day 30|Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS), Up to Day 30|Echocardiographic measures of cardiac systolic function: left ventricle stroke volume (LVSV), Up to Day 30|Echocardiographic measures of cardiac diastolic function: lateral early diastolic mitral annular velocity (e'), Up to Day 30|Echocardiographic measures of cardiac diastolic function: septal e', Up to Day 30|Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e'), Up to Day 30|Echocardiographic measures of cardiac diastolic function: early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio), Up to Day 30|Echocardiographic measures of cardiac structure: LV mass index, Up to Day 30|Echocardiographic measures of cardiac structure: LV atrial volume index, Up to Day 30|Echocardiographic measures of cardiac structure: interventricular septal thickness, Up to Day 30|Echocardiographic measures of cardiac structure: posterior wall thickness, Up to Day 30|Echocardiographic measures of cardiac structure: LV end diastolic volume, Up to Day 30|Echocardiographic measures of cardiac structure: LV end systolic volume, Up to Day 30|Echocardiographic measures of cardiac structure: LV end systolic volume index, Up to Day 30