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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: BMS-986435

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Xuhui District, Shanghai, China, 200032
      • Local Institution - 0001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: BMS-986435; Specified dose on specified days; Other Names: MYK-224
Experimental: Arm 2	Drug: BMS-986435; Specified dose on specified days; Other Names: MYK-224

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2024
• Primary Completion (Actual): October 11, 2024
• Study Completion (Actual): October 11, 2024

Study Registration Dates

• First Submitted: June 21, 2024
• First Submitted That Met QC Criteria: June 21, 2024
• First Posted (Actual): June 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CV029-1010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes