Drug-drug interaction study in healthy men and women not of childbearing potential. Assess the effect of BMS-986195 on the pharmacokinetics of methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on safety of BMS-986195 and methotrexate, caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin. Collect data on multiple-dose pharmacodynamics of BMS-986195.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
26
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
PPD Development, LP
Austin, Texas, United States
Maximum observed plasma concentration (Cmax)
Measured by plasma concentrations
Time frame: Up to 26 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))
Measured by plasma concentrations
Time frame: Up to 26 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentrations
Time frame: Up to 26 days
Number of participants with adverse events
Measured by investigator assessment
Time frame: Up to 28 days
Number of participants with serious adverse events
Measured by investigator assessment
Time frame: Up to 45 days
Number of participants with adverse events leading to discontinuation
Measured by investigator assessment
Time frame: Up to 28 days
Number of participants with clinical laboratory test abnormalities
Time frame: Up to 28 days
Number of participants with vital sign measurement abnormalities
Time frame: Up to 28 days
Number of participants with electrocardiogram abnormalities
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Time frame: Up to 28 days
Number of participants with physical examination abnormalities
Time frame: Up to 28 days
Number of participants with marked abnormalities in clinical laboratory test results
Time frame: Up to 28 days