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
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