A Study to Evaluate the Safety, Tolerability, Drug Levels, and Drug Effects of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BMS-986435

• Registration Number: NCT06476821
• Lead Sponsor: Bristol-Myers Squibb

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-21
• Study First Submitted QC: 2024-06-21
• Study First Posted: 2024-06-26
• Study Start: 2024-06-27
• Primary Completion: 2024-10-11
• Study Completion: 2024-10-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-16
• Last Update Posted: 2024-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Body weight of ≥ 50 kg and body mass index between 18.0 and 28.0 kg/m2, inclusive, at screening.
• Participants must be Chinese (both biological parents are ethnically Chinese).
• Participant has documented LVEF ≥ 60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.

Exclusion Criteria

• Any acute or chronic medical illness.
• Head injury in the last 2 years, intracranial tumor, or aneurysm.
• History of malignancy of any type, except in situ cervical cancer > 5 years prior to the screening visit or surgically excised nonmelanomatous skin cancers > 2 years prior to the screening visit.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	BMS-986435	-
Arm 2	BMS-986435	-

Primary Outcome Measures

Name	Time	Method
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
Maximum observed concentration (Cmax)	Up to Day 30

Secondary Outcome Measures

Name	Time	Method
Number of participants with AEs leading to discontinuation	From date of written consent up to 28 days post last dose
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 vital sign abnormalities	Up to Day 31
Number of participants with electrocardiogram (ECG) abnormalities	Up to Day 31
Number of participants with physical examination 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 fractional shortening (LVFS)	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 structure: posterior wall thickness	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 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: LV end systolic volume	Up to Day 30
Number of participants with echocardiogram abnormalities	Up to Day 30
Number of participants with clinical laboratory abnormalities	Up to Day 31
Echocardiographic measures of cardiac systolic function: left ventricular global longitudinal strain (LV GLS)	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 index	Up to Day 30

Trial Locations

Locations (1)

Local Institution - 0001; 🇨🇳 Xuhui District, Shanghai, China