Healthy Participants, Hepatic Impairment
Conditions
Keywords
Healthy Volunteers, Pharmacokinetics, Liver Diseases, Mild, Moderate and Severe Hepatic Impairment, BMS-986278
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.
Interventions
DRUGBMS-986278
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of participants with vital sign abnormalities | Up to 62 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 62 days |
| Number of participants with clinical laboratory abnormalities | Up to 62 days |
| Time of maximum observed concentration (Tmax) | Up to day 9 |
| Incidence of adverse events (AEs) | Up to 62 days |
| Apparent body clearance (CLT/F) | Up to day 9 |
| Maximum observed plasma concentration of unbound drug (Cmax_u) | Up to day 9 |
| 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 |
| Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u] | Up to day 9 |
| Terminal elimination half-life (T-HALF) | Up to day 9 |
| Incidence of serious adverse events (SAEs) | Up to 62 days |
| Number of participants with physical examination abnormalities | Up to 62 days |
Countries
United States
Outcome results
None listed