The purpose of this study is to investigate the effects of BMS-986165 on the drug levels of metformin in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Specified dose on specified days
Specified dose on specified days
PRA Health Sciences - Lenexa
Lenexa, Kansas, United States
Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165
Time frame: Up to 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165
Time frame: Up to 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for metformin with and without BMS-986165
Time frame: Up to 9 days
Incidence of adverse events (AEs)
Time frame: Up to 13 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 71 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 41 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
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Time frame: Up to 41 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to 41 days
Incidence of clinically significant changes in electrocardiogram (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 41 days
Incidence of clinically significant changes in electrocardiogram (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 41 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 41 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 41 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 41 days