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

NCT07248839 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: CV029-1017
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers; Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• 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

Study Arms (3)

Arm A

EXPERIMENTAL

Mild Hepatic Impairment

Drug: BMS-986435

Arm B

EXPERIMENTAL

Moderate Hepatic Impairment

Drug: BMS-986435

Arm C

EXPERIMENTAL

Matched participants with normal hepatic function

Drug: BMS-986435

Interventions

BMS-986435 DRUG

Specified dose on specified days

Also known as: MYK-224

Arm A; Arm B; Arm C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain the NCT# and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: December 15, 2025
• Primary Completion: April 6, 2026
• Study Completion: April 6, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description