A Study to Evaluate the Drug Levels, Safety, and Tolerability of BMS-986036 in Participants With Normal Liver Function and Participants With Moderate and Severe Liver Impairment
Phase 1
Completed
- Conditions
- Moderate Liver ImpairmentSevere Liver Impairment
- Interventions
- Registration Number
- NCT04634149
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: Moderate Hepatic Impairment BMS-986036 - Group B: Severe Hepatic Impairment BMS-986036 - Group C: Normal Hepatic Function BMS-986036 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Number of participants with vital sign abnormalities Up to 31 days Number of participants with electrocardiogram (ECG) abnormalities Up to 31 days Number of participants with adverse events (AEs) Up to 31 days Number of participants with clinical laboratory abnormalities Up to 31 days Number of participants with physical examination abnormalities Up to 31 days 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
Trial Locations
- Locations (3)
Local Institution - 0002
🇺🇸Miami, Florida, United States
Local Institution - 0001
🇺🇸San Antonio, Texas, United States
Local Institution
🇺🇸Orlando, Florida, United States