Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic Impairment
- Registration Number
- NCT06425198
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the drug levels and safety of BMS-986278 in participants with mild, moderate, and severe Hepatic Impairment (HI), and in matched healthy control participants with normal hepatic function.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
All Participants:
- Must have a body mass index (BMI) between 18 and 40 kg/m^2 (inclusive), and body weight ≥ 50 kg.
Mild, Moderate, or Severe Hepatic Impairment Participants:
- Mild, moderate, or severe hepatic impairment (HI) or cirrhosis due to chronic hepatic disease and/or prior alcohol use.
- Mild, moderate, and severe HI participants will be enrolled according to the Child-Pugh classification score.
Matched Healthy Participants:
- Free of any clinically significant disease that would interfere with the study evaluations.
- Normal hepatic function participants will be enrolled and matched individually with HI participants with respect to age (± 10 years), weight (± 20%), sex, and race/ethnicity (Japanese and Chinese participants vs non-Japanese and non-Chinese participants).
Exclusion Criteria
All Participants:
- History of alcohol abuse within 1 year prior to screening or regular use of alcohol within 6 months prior to screening that exceeds 7 units for women, or 14 units for men of alcohol per week (1 unit = 340 mL of beer 5%, 140 mL of wine 12%, or 45 mL of distilled alcohol 40%).
- Must not have had any prior exposure to BMS-986278.
Mild, Moderate, or Severe Hepatic Impairment Participants:
- Acute liver disease (eg, caused by an acute infection or drug toxicity).
- History of initial stage/planned liver transplantation within 6 months of screening or has received a liver transplant.
Matched Healthy Participants:
- Any significant medical condition, or psychiatric illness that would prevent participant from participating in the study.
- Other protocol-defined inclusion/exclusion criteria apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Mild Hepatic Impairment BMS-986278 BMS-986278 - Group B: Moderate Hepatic Impairment BMS-986278 BMS-986278 - Group C: Severe Hepatic Impairment BMS-986278 BMS-986278 - Group D: Normal Hepatic Function BMS-986278 BMS-986278 -
- Primary Outcome Measures
Name Time Method Maximum observed concentration (Cmax) Up to day 9 Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] Up to day 9 Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] Up to day 9
- Secondary Outcome Measures
Name Time Method Number of participants with vital sign abnormalities Up to 62 days Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u] Up to day 9 Time of maximum observed concentration (Tmax) Up to day 9 Incidence of serious adverse events (SAEs) Up to 62 days Maximum observed plasma concentration of unbound drug (Cmax_u) Up to day 9 Incidence of adverse events (AEs) Up to 62 days Apparent body clearance (CLT/F) Up to day 9 Number of participants with electrocardiogram (ECG) abnormalities Up to 62 days Number of participants with clinical laboratory abnormalities Up to 62 days Terminal elimination half-life (T-HALF) Up to day 9 Number of participants with physical examination abnormalities Up to 62 days Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration of unbound drug [AUC(0-T)_u] Up to day 9
Trial Locations
- Locations (4)
Local Institution - 0002
🇺🇸Tampa, Florida, United States
Local Institution - 0001
🇺🇸Miami Lakes, Florida, United States
Local Institution - 0003
🇺🇸Orlando, Florida, United States
Local Institution - 0004
🇺🇸San Antonio, Texas, United States