A Phase 1, Multi-center, Open-label, Single-dose Study to Assess the Pharmacokinetics and Safety of BMS-986435 in Participants With Normal Hepatic Function and Participants With Mild and Moderate Hepatic Impairment
Bristol-Myers Squibb
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- Yes
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…
Interventions
- DrugBMS-986435
Specified dose on specified days
Locations (3)
- Arizona Clinical TrialsChandler, Arizona
- Panax Clinical ResearchMiami Lakes, Florida
- Texas Liver InstituteSan Antonio, Texas