The purpose of this study is to evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
40
Specified dose on specified days
Specified dose on specified days
ICON Plc (Legacy PRA)
Lenexa, Kansas, United States
Incidence of non-serious Adverse Events (AEs)
Time frame: Up to 35 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 35 days
Incidence of AEs leading to discontinuation of study treatment
Time frame: Up to 35 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 28 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 28 days
Incidence of clinically significant changes in physical examination
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Chemistry tests
Time frame: Up to 28 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 28 days
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Incidence of clinically significant changes in clinical laboratory values: Serology tests
Time frame: Up to 28 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 28 days
Plasma concentrations of BMS-986172
Time frame: Up to 28 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 28 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 28 days