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NCT07248839PHASE1RecruitingAccepts Healthy Volunteers

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

Bristol-Myers Squibb

Start Date

12/15/2025

Completion Date

8/5/2026

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

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

BMS-986435

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Conditions

Healthy VolunteersHepatic Impairment

Locations

Arizona Clinical Trials

Chandler, Arizona 85225

United States

Panax Clinical Research

Miami Lakes, Florida 33014

United States

Texas Liver Institute

San Antonio, Texas 78215

United States