The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
22
Specified dose on specified days
Specified dose on specified days
PPD Development, LP
Austin, Texas, United States
Maximum observed plasma concentration (Cmax) of BMS-986256
Time frame: Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
Time frame: Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
Time frame: Up to 19 days
Incidence of Adverse Events (AEs)
Time frame: Up to 45 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time frame: Up to 45 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 45 days
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Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 45 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 45 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
Time frame: Up to 45 days
Incidence of 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 45 days
Incidence of 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 45 days
Incidence of 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 45 days
Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)
Time frame: Up to 45 days
Time of maximum observed plasma concentration (Tmax) of BMS-986256
Time frame: Up to 45 days
Apparent terminal plasma half-life (T-HALF) of BMS-986256
Time frame: Up to 45 days
Apparent total body clearance (CLT/F) of BMS-986256
Time frame: Up to 45 days
Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256
Time frame: Up to 45 days