The main objectives of this study are to characterize the PK of BMS-986278 after administration of a single dose of BMS-986278 alone or in combination with pirfenidone, as well as to characterize the PK of pirfenidone after administration of a single dose of pirfenidone alone or in combination with BMS-986278
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
suspension
capsule
PRA Health Sciences - Salt Lake
Salt Lake City, Utah, United States
Maximum observed serum concentration (Cmax) of BMS-986278 and pirfenidone alone or in combination
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986278 and pirfenidone alone or in combinaton
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Area under the plasma concentration-time curve extrapolated to infinity [(AUC(INF)] of BMS-986278 and pirfenidone alone or in combinaton
Time frame: Up to day 5 of each period (Each period is 7 days; 3 periods total)
Incidence of AEs (adverse events), SAEs (serious adverse events), and AEs leading to discontinuation
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Clinical Laboratory Values
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Vital Signs
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG)
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
Number of Participants With Clinically Significant Change in Physical Examination
Time frame: Up to Day 8 of Period 3 (each period is 7 days; 3 periods total)
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Volume of distribution at terminal phase (VzF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of BMS-986278 and metabolite alone or in combination with pirfenidone
Time frame: Up to Day 5 of period 3 (each period is 7 days; 3 periods total)
Time of maximum observed serum concentration (Tmax) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Elimination half-life (T-HALF) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Oral clearance (CL/F) of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Volume of distribution at terminal phase (VzF) Plasma Pharmokinetics of pirfenidone and metabolite alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Renal clearance (Clr) in Urine of pirfenidone alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)
Cumulative amount recovered in urine [Ae(0-T)] of pirfenidone alone or in combination with BMS-986278
Time frame: Up to Day 5 of Period 3 (each period is 7 days; 3 periods total)