This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Tempe, Arizona, United States
Maximum observed plasma concentration (Cmax)
Time frame: Up to 11 days
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Time frame: Up to 11 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time frame: Up to 11 days
Number of participants with adverse events (AEs)
Time frame: Up to 41 days
Number of participants with physical examination abnormalities
Time frame: Up to 17 days
Number of participants with vital sign abnormalities
Time frame: Up to 17 days
Number of participants with electrocardiogram (ECG) abnormalities
Time frame: Up to 17 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 17 days
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 17 days
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