The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986166 in healthy Japanese male and female participants of non-childbearing potential.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
23
Specified dose on specified days
Specified dose on specified days
West Coast Clinical Trials Global
Cypress, California, United States
Pharmacokinetic (PK) parameters of BMS-986166: Maximum observed blood concentration (Cmax)
Time frame: Day 1, Day 28
PK parameters of BMS-986166: Time of maximum observed blood concentration (Tmax)
Time frame: Day 1, Day 28
PK parameters of BMS-986166: Area under the concentration-time curve within a dosing interval (AUC(TAU))
Time frame: Day 1, Day 28
PK parameters of BMT-121795: Cmax
Time frame: Day 1, Day 28
PK parameters of BMT-121795: Tmax
Time frame: Day 1, Day 28
PK parameters of BMT-121795: AUC(TAU)
Time frame: Day 1, Day 28
Incidence of all adverse events (AEs)
Time frame: Up to 77 days
Severity of all AEs
Time frame: Up to 77 days
Outcome of all AEs
Time frame: Up to 77 days
Incidence of all serious adverse events (SAEs)
Time frame: Up to 77 days
Severity of all SAEs
Time frame: Up to 77 days
Outcome of all SAEs
Time frame: Up to 77 days
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Severity of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Investigator causality assessment of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Outcomes of all AEs regardless of seriousness criteria
Time frame: Up to 77 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 77 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time frame: Up to 77 days
Incidence of clinically significant changes in ECG parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time frame: Up to 77 days
Incidence of clinically significant changes in continuous cardiac monitoring data
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 77 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in electrocardiogram (ECG) parameters: PR interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QRS interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QT interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in ECG parameters: QTcF interval
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in continuous cardiac monitoring data
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Body temperature
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Respiratory rate
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Blood pressure
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in vital signs: Heart rate
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Hematology tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 77 days
Incidence of clinically significant changes from baseline values in clinical laboratory results: Urinalysis tests
Time frame: Up to 77 days