The objective of this study is to assess the pharmacokinetics (PK) and absolute bioavailability of BMS-986365 and to investigate the PK, metabolite profile, routes and extent of elimination, and mass balance of BMS-986365.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Specified dose on specified days
Specified dose on specified days.
Specified dose on specified days
Local Institution - 0001
Madison, Wisconsin, United States
Maximum observed concentration (Cmax)
Part A and B
Time frame: Up to Day 60
Time of maximum observed concentration (Tmax)
Part A and B
Time frame: Up to Day 60
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Part A and B
Time frame: Up to Day 60
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC (INF))
Part A and B
Time frame: Up to Day 60
Apparent terminal plasma half-life (T-HALF)
Part A and B
Time frame: Up to Day 60
Total body clearance (CLT)
Part A
Time frame: Up to Day 15
Apparent total body clearance (CLT/F)
Part A and B
Time frame: Up to Day 60
Mean residence time (MRT)
Part A
Time frame: Up to Day 15
Apparent volume of distribution (Vz)
Part A
Time frame: Up to Day 15
Apparent volume of distribution (Vz/F)
Part A and B
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Specified dose on specified days
Time frame: Up to Day 60
Absolute bioavailability (F)
Part A
Time frame: Up to Day 15
Number of participants with Adverse Events
Part A and B
Time frame: Up to Day 60
Number of participants with Serious Adverse Events
Part A and B
Time frame: Up to Day 60
Number of participants with AEs leading to discontinuation
Part A and B
Time frame: Up to Day 60
Number of participants with Vital sign abnormalities
Part A and B
Time frame: Up to Day 60
Number of participants with electrocardiogram (ECG) abnormalities
Part A and B
Time frame: Up to Day 60
Number of participants with physical examination abnormalities
Part A and B
Time frame: Up to Day 60
Number of participants with clinical laboratory abnormalities
Part A and B
Time frame: Up to Day 60