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
Recruiting now · Phase 1
Conditions studied: Healthy Volunteers, Hepatic Impairment
In brief
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
Key facts
- Study ID
- NCT07248839
- Run by
- Bristol-Myers Squibb
- People needed
- 24
- Starts
- 2025-12-15
- Expected to finish
- 2026-08-05
- Last updated by the study team
- 2026-06-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
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).
- Other protocol defined inclusion/exclusion criteria applies.
Where it is running
- Arizona Clinical Trials — Chandler, Arizona, United States (enrolling)
- Panax Clinical Research — Miami Lakes, Florida, United States (enrolling)
- Texas Liver Institute — San Antonio, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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