This study will evaluate the effect of inhibitors, at steady state, on the drug levels, safety, and tolerability of BMS-986235 when taken by healthy participants. The inhibitors to be utilized in this study are fluconazole, bupropion, and itraconazole.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
Local Institution
Lenexa, Kansas, United States
Local Institution
Salt Lake City, Utah, United States
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with fluconazole
Time frame: Day 12
Maximum plasma concentration (Cmax) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with fluconazole
Time frame: Day 12
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with bupropion
Time frame: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with bupropion
Time frame: Day 13
Maximum plasma concentration (Cmax) of BMS-986235 with bupropion
Time frame: Day 13
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235 with itraconazole
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235 with itraconazole
Time frame: Day 9
Maximum plasma concentration (Cmax) of BMS-986235 with itraconazole
Time frame: Day 9
Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC(INF)) of BMS-986235
Time frame: Day 1
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Specified Dose on Specified Days
Area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration (AUC(0-T)) of BMS-986235
Time frame: Day 1
Maximum plasma concentration (Cmax) of BMS-986235
Time frame: Day 1
Incidence of Nonserious Adverse Events (AEs)
Time frame: Up to 49 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 77 days
Incidence of AEs leading to discontinuation
Time frame: Up to 16 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 44 days
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Hematology
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Clinical Chemistry
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Coagulation
Time frame: Up to 44 days
Number of clinically significant changes in clinical laboratory tests: Urinalysis
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 44 days
Number of clinically significant changes from baseline in vital signs:Blood Pressure
Time frame: Up to 44 days
Number of clinically significant changes in electrocardiogram (ECG)
Time frame: Up to 44 days
Number of clinically significant changes in vital signs: Oxygen saturation (the amount of oxygen in blood (SpO2))
Time frame: Up to 44 days