The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
15
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Hassman Research Institute
Berlin, New Jersey, United States
Maximum observed plasma concentration (Cmax) of BMS-986166
Time frame: Up to Day 22
Cmax of BMT-121795
Time frame: Up to Day 22
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Time frame: Up to Day 22
Tmax of BMT-121795
Time frame: Up to Day 22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
Time frame: Up to Day 22
AUC(0-T) of BMT-121795
Time frame: Up to Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
Time frame: Up to Day 22
AUC(INF) of BMT-121795
Time frame: Up to Day 22
Terminal plasma half-life (T-HALF) of BMS-986166
Time frame: Up to Day 22
T-HALF of BMT-121795
Time frame: Up to Day 22
Apparent total body clearance (CL/F) of BMS-986166
Time frame: Up to Day 22
Apparent volume of distribution (Vz/F) of BMS-986166
Time frame: Up to Day 22
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Specified dose on specified days
Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
Time frame: Up to Day 22
Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
Time frame: Up to Day 22
Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
Time frame: Up to Day 22
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 55
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 55
Number of participants with physical examination abnormalities
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Body temperature
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Respiratory rate
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Blood pressure
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Heart rate
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Hematology tests
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Urinalysis
Time frame: Up to Day 55