The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986337 in healthy participants and in healthy Japanese participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
26
Specified Dose on Specified Days
Specified Dose on Specified Days
Specified Dose on Specified Days
ICON Plc (PRA Health Sciences) - Netherlands
Groningen, Netherlands
Incidence of Adverse Events (AEs)
Time frame: Up to 30 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 81 days
Incidence of AEs leading to discontinuation
Time frame: Up to 30 days
Number of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 51 days
Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Heart Rate
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Body Temperature
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Blood Pressure
Time frame: Up to 51 days
Number of clinically significant changes from baseline in vital signs: Respiratory Rate
Time frame: Up to 51 days
Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)
Time frame: Up to 51 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Number of clinically significant changes from baseline in physical examinations
Time frame: Up to 51 days
Number of 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 51 days
Number of clinically significant changes in ECG parameters: QRS duration
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to 51 days
Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)
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 51 days
Number 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 51 days