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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
Specified dose on specified days
Local Institution - 0001
Miami Lakes, Florida, United States
Local Institution - 0003
Orlando, Florida, United States
Local Institution - 0002
Tampa, Florida, United States
Local Institution - 0004
San Antonio, Texas, United States
Maximum observed concentration (Cmax)
Time frame: Up to day 9
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to day 9
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to day 9
Incidence of adverse events (AEs)
Time frame: Up to 62 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 62 days
Number of participants with physical examination abnormalities
Time frame: Up to 62 days
Number of participants with vital sign abnormalities
Time frame: Up to 62 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 62 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 62 days
Time of maximum observed concentration (Tmax)
Time frame: Up to day 9
Terminal elimination half-life (T-HALF)
Time frame: Up to day 9
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Apparent body clearance (CLT/F)
Time frame: Up to day 9
Maximum observed plasma concentration of unbound drug (Cmax_u)
Time frame: 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]
Time frame: Up to day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinite time of unbound drug [AUC(INF)_u]
Time frame: Up to day 9