A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986435 (MYK-224) in Healthy Chinese Participants

Bristol-Myers Squibb1 site in 1 country20 target enrollmentJune 27, 2024

ConditionsHealthy Volunteers

InterventionsBMS-986435

DrugsBMS-986435

Overview

Phase: Phase 1
Intervention: BMS-986435
Conditions: Healthy Volunteers
Sponsor: Bristol-Myers Squibb
Enrollment: 20
Locations: 1
Primary Endpoint: Time of maximum observed concentration (Tmax)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2024

End Date

October 11, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

Arm 1

Intervention: BMS-986435

Arm 2

Intervention: BMS-986435

Outcomes

Primary Outcomes

Time of maximum observed concentration (Tmax)

Time Frame: Up to Day 30

Area under the concentration time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))

Time Frame: Up to Day 30

Maximum observed concentration (Cmax)

Time Frame: Up to Day 30

Secondary Outcomes

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)