A Study to Assess the Drug Levels and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Different Degrees of Hepatic Impairment

A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment

The purpose of this study is to determine the pharmacokinetic and safety of BMS-986435 in participants with normal hepatic function and participants with different degrees of hepatic impairment

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers; Hepatic Impairment
• Intervention / Treatment: Drug: BMS-986435

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain the NCT# and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Participant must have documented LVEF ≥ 60% (2D biplane Simpson's Method) and absence of cardiac abnormality.
• Participant must have body weight of > 50 kg and BMI of 18.0 kg/m2 through 40 kg/m2, inclusive, at screening.
• Participants must have adequate renal function at screening as evidenced by an eGFR > 60 mL/min/1.73 m2 for participants calculated with the CKD-EPI Creatinine Equation (2021).

Exclusion Criteria:

• Participants must not have history of or current uncontrolled or unstable clinically significant disorder, condition, or disease that, in the opinion of the investigator and CRO MM, would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion.
• Participants must not have head injury in the last 2 years, intracranial tumor, or aneurysm.
• Participants must not have history of malignancy of any type, except in situ cervical cancer >5 years prior to the screening visit or surgically excised non-melanomatous skin cancer >2 years prior to the screening visit.
• Participants must not have History of heart disease (including coronary artery disease, heart failure/LV systolic dysfunction, cardiomyopathy, or clinically significant structural disease).
• Other protocol defined inclusion/exclusion criteria applies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A; Mild Hepatic Impairment	Drug: BMS-986435; Specified dose on specified days; Other Names: MYK-224
Experimental: Arm B; Moderate Hepatic Impairment	Drug: BMS-986435; Specified dose on specified days; Other Names: MYK-224
Experimental: Arm C; Matched participants with normal hepatic function	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 45
Area under the concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)	Up to Day 45
Area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)	Up to Day 45

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of participants with adverse events (AEs)	Up to Day 45
Number of participants with serious adverse events (SAEs)	Up to Day 45
Time of maximum observed concentration (Tmax)	Up to Day 45
Half-life (T-HALF)	Up to Day 45
Apparent total body clearance (CLT/F)	Up to Day 45
Apparent volume of distribution at terminal phase (Vz/F)	Up to Day 45

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 (Estimated): December 15, 2025
• Primary Completion (Estimated): April 6, 2026
• Study Completion (Estimated): April 6, 2026

Study Registration Dates

• First Submitted: November 18, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 25, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: CV029-1017

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 Myers 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