What is BMS-986435 studying for hepatic impairment?

BMS-986435 is being studied to understand how the drug is processed and its safety in people with normal and impaired liver function. This helps researchers learn how liver health affects the drug's behavior. The study is sponsored by Bristol-Myers Squibb and includes healthy volunteers and participants with liver impairment.

Who may be eligible for this hepatic impairment clinical trial?

Adults aged 18 to 75 years with normal or mildly to moderately impaired liver function may be eligible. Participants should have good heart and kidney function and weigh more than 50 kg with a BMI between 18.0 and 40 kg/m2. Please review eligibility criteria for more details.

Is there any cost to participate in this hepatic impairment clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. However, personal travel expenses to and from the study site may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Age: 18Years - 75Years

All Genders

Healthy Volunteers

ID07248839

Phase 1 Study of BMS-986435 Drug Levels and Safety in Adults with Normal Liver Function or Mild to Moderate Liver Impairment

Led by Bristol-Myers Squibb · Updated on 2026-06-12

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the pharmacokinetics and safety of the drug BMS-986435 in adults with normal liver function and those with mild or moderate liver impairment. The study aims to understand how the drug behaves in the body and its safety profile across these different liver function groups. This is a Phase 1, open-label study involving healthy volunteers and participants with hepatic impairment. Participants receive a single specified dose of BMS-986435. The study includes three groups those with mild hepatic impairment, moderate hepatic impairment, and matched participants with normal liver function. The study uses a parallel design and is non-randomized, with no blinding. During the study, participants will undergo assessments up to 45 days after dosing to measure drug concentration levels, including maximum concentration and the area under the concentration-time curve. Safety is monitored by recording adverse events and serious adverse events. Additional measures include drug half-life, time of maximum concentration, clearance, and volume of distribution. Participants must meet specific health criteria including adequate heart and kidney function. The total participation duration extends through these evaluation periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

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.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

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