Hepatic Impairment
Conditions
Brief summary
An oral dose of BMS-986141 administered in Hepatic Impairment and Healthy Participants to evaluate pharmacokinetics in this patient population.
Interventions
DRUGBMS-986141
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 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Women not of childbearing potential (WNOCBP), and males, ages 18 to 70 years, inclusive. * BMI of 20.0 to 38.0 kg/m2 inclusive * Participants who a history of normal renal function * Subjects with hepatic impairment must be on a stable dose of medication and/or treatment regimen * Healthy subjects to the extent possible matched to four subjects with hepatic impairment with regard to body weight, age and gender, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Exclusion criteria
* Any nonhepatic significant acute or chronic medical illness that could affect participant safety or data interpretation as determined by the investigator. * History of recurrent dizziness or fall risk within 4 weeks of study drug administration * History of primarily cholestatic liver diseases, autoimmune liver disease, metastatic liver disease or active alcoholic hepatitis * History of known bleeding diathesis or coagulation disorder (eg, thrombotic thrombocytopenic purpura) * Other protocol defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
| Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
| Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
| Area under the plasma concentration-time curve from time zero to 144 hours postdose (AUC(0-144h)) of BMS-986141 | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
Secondary
| Measure | Time frame |
|---|---|
| Safety endpoints include the incidence of adverse events (AEs), serious adverse events (SAEs), leading to discontinuation. | Days 1-7 (healthy) Days 1-10 (heaptic Impairment) |
Countries
United States
Outcome results
None listed