Hepatic Impairment
Conditions
Brief summary
The primary purpose of this study is to evaluate the effect of liver impairment on the safety and pharmacokinetics (PK) of BMS-986263
Interventions
DRUGBMS-986263
Single Dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * BMI ≥ 18 kg/m\^2 and weight ≥ 50 kg at screening (BMI = weight \[kg\]/height \[m\^2\]). * Participants with normal hepatic function as judged by the investigator * Participants with hepatic impairment as judged by the investigator
Exclusion criteria
* Clinically relevant abnormal medical history, abnormal findings on physical examination, vital signs, ECG, or laboratory tests at screening that the investigator judges as likely to interfere with the objectives of the trial or the safety of the participant. * Any major surgery within 4 weeks of study drug administration * Previous exposure to BMS-986263 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Area under the serum concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Total body clearance (CL) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Volume of distribution (Vz) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Terminal elimination half-life (T-Half) of components of BMS-986263 for injection | Day 1 to Day 31 |
| Maximum observed serum concentration (Cmax) of components of BMS-986263 for injection | Day 1 to Day 31 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | Up to 31 days |
| Number of participants with physical examination abnormalities | Up to 59 days |
| Incidence of Serious Adverse Events (SAEs) | Up to 59 days or up to 30 days after dosing (whichever is longer) |
| Incidence of AEs leading to discontinuation | Nonserious AEs: Up to 31 days ; SAEs: Up to 59 days or up to 30 days after dosing (whichever is longer). |
| Number of participants with abnormalities in clinical laboratory assessments | Up to 59 days |
| Number of participants with vital sign abnormalities | Up to 59 days |
| Number of participants with 12-lead electrocardiogram (ECG) abnormalities | Up to 59 days |
Countries
United States
Outcome results
None listed