The purpose of this study is to assess the effect of severe renal impairment (RI) and end-stage renal disease (ESRD) with intermittent hemodialysis (IHD) on the pharmacokinetics and safety of BMS-986278. This study plans to use a staged design based on RI severity.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Specified dose on specified days
Local Institution - 0002
Miami, Florida, United States
Local Institution - 0003
Miami, Florida, United States
Local Institution - 0004
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Maximum observed concentration (Cmax)
Time frame: Up to Day 8
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Time frame: Up to Day 8
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Time frame: Up to Day 8
Number of participants with adverse events (AEs)
Time frame: Up to 28 days following discontinuation of dosing
Number of participants with physical examination abnormalities
Time frame: Up to Day 8
Number of participants with vital sign abnormalities
Time frame: Up to Day 8
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
Time frame: Up to Day 8
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 8
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 8
Terminal elimination half-life (T-HALF)
Time frame: Up to Day 8
Apparent body clearance (CLT/F)
Time frame: Up to Day 8
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Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Up to Day 8
Concentration of BMS-986278 in dialysate
Time frame: Up to Day 8
Total amount recovered in dialysate (DR)
Time frame: Up to Day 8
Total percent of administered dose recovered in dialysate (%DR)
Time frame: Up to Day 8
Free fraction of unbound drug (Fu)
Time frame: Up to Day 8
Unbound Cmax (Cmax_u)
Time frame: Up to Day 8
Unbound AUC(0-T) (AUC(0-T) _u)
Time frame: Up to Day 8
Unbound AUC(INF) (AUC(INF)_u)
Time frame: Up to Day 8
Unbound CLT/F (CLT/F_u)
Time frame: Up to Day 8
Unbound Vz/F (Vz/F_u)
Time frame: Up to Day 8