The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986308 compared to placebo in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
46
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
Lenexa, Kansas, United States
Incidence of Adverse Events (AEs)
Part B
Time frame: Up to 19 days
Incidence of serious adverse events (SAEs)
Part B
Time frame: Up to 19 days
Incidence of death
Part B
Time frame: Up to 19 days
Incidence of adverse events (AEs) leading to discontinuation
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in vital signs: Supine blood pressure
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in vital signs: Heart rate
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Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in vital signs: Orthostatic hypotension measurements performed as per clinical research unit's standard operating procedure
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
Part B PR interval is the time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 19 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
Part B QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to 19 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
Part B The QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to 19 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
Part B 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 19 days
Incidence of clinically significant changes in cardiac telemetry
Part B
Time frame: Up to 19 days
Incidence of clinically significant changes in physical examination findings
Part B
Time frame: Up to 19 days