Moderate Liver Impairment, Severe Liver Impairment
Conditions
Keywords
Cirrhosis, Hepatic impairment, Liver impairment, Nonalcoholic steatohepatitis (NASH)
Brief summary
The purpose of this study is to investigate the effect of impaired liver function on the drug levels, safety, and tolerability of BMS-986036 in participants with moderate and severe liver impairment. Results from this study will be used to determine whether dose adjustment is required for patients with decreased liver function.
Interventions
DRUGBMS-986036
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
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy participants or participants with hepatic impairment, as determined by medical history, physical exam, electrocardiogram (ECG), and clinical laboratory determinations * Body mass index (BMI) of 18.0 kg/m\^2 to 40.0 kg/m\^2, inclusive. BMI = weight (kg)/height (m\^2)
Exclusion criteria
* Any history of known or suspected congenital or acquired immunodeficiency state or condition that would have compromised the participant's immune status * History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) | Up to 29 days |
| Time of maximum observed plasma concentration (Tmax) | Up to 29 days |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) | Up to 29 days |
Secondary
| Measure | Time frame |
|---|---|
| Time of maximum observed plasma concentration (Tmax) | Up to 29 days |
| Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration(AUC(0-T)) | Up to 29 days |
| Number of participants with electrocardiogram (ECG) abnormalities | Up to 31 days |
| Number of participants with clinical laboratory abnormalities | Up to 31 days |
| Number of participants with vital sign abnormalities | Up to 31 days |
| Number of participants with adverse events (AEs) | Up to 31 days |
| Number of participants with physical examination abnormalities | Up to 31 days |
| Maximum observed plasma concentration (Cmax) | Up to 29 days |
Countries
United States
Outcome results
None listed