The Purpose of the Study is to Assess the Drug Interaction and Bioavailability of BMS-986278 in Tablet Formulations and the Effect that Food has on BMS-986278 in Tablet Formulation in Healthy Participants
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
Specified Dose on specified days
Specified dose on specified days
Local Institution - 0001
Lenexa, Kansas, United States
Maximum Observed Serum Concentration (Cmax)
Time frame: Days 4, 17, 21 (Part-1); Days 1, 7, 13 (Part-2); Days 1, 7 (Part-3)
Area under the plasma concentration-time curve within a dosing interval AUC(TAU)
Time frame: Day 4, 17 and 21 of Part 1
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-T)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Number of participants with non-serious AEs (Adverse events)
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with Serious AEs
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with AEs leading to discontinuation
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with Physical examination abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with vital sign abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with 12-lead electrocardiogram (ECG) abnormalities
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Time frame: Up to 28 Days post discontinuation of dosing
Number of participants with clinical laboratory abnormalities
Time frame: Up to 28 Days post discontinuation of dosing
Time of maximum observed plasma concentration (Tmax)
Time frame: Day 4, 17, 21 (Part-1), Day 1 (part-2 and Part-3), Day 7 (Part2 and 3), Day 13) (Part-2)
Apparent terminal phase half-life (T-HALF)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent total body clearance (CLT/F)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)
Apparent volume of distribution of terminal phase (Vz/F)
Time frame: Day 1-6 (part-2 and Part-3), Day 7-12 (Part2 and 3), Day 13-18) (Part-2)