The purpose of this study is to evaluate the effect of BMS-986278 on the cardiac repolarization in healthy participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
32
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Local Institution - 0001
San Antonio, Texas, United States
Change from baseline Fridericia's corrected QT interval (QTcF) (ΔQTcF)
Time frame: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: Up to Day 13
Change from baseline heart rate (HR)
Time frame: Up to Day 13
Placebo-corrected change from baseline HR
Time frame: Up to Day 13
Change from baseline PR interval
Time frame: Up to Day 13
Placebo-corrected change from baseline PR interval
Time frame: Up to Day 13
Change from baseline QRS interval
Time frame: Up to Day 13
Placebo-corrected change from baseline QRS interval
Time frame: Up to Day 13
Number of participants with categorical outliers for QTcF
Time frame: Up to Day 13
Number of participants with categorical outliers for HR
Time frame: Up to Day 13
Number of participants with categorical outliers for PR interval
Time frame: Up to Day 13
Number of participants with categorical outliers for QRS interval
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Time frame: Up to Day 13
Number of participants with treatment-emergent changes of electrocardiogram (ECG) morphology
Time frame: Up to Day 13
Change from baseline QTcF (ΔQTcF)
Time frame: Up to Day 13
Placebo-corrected change from baseline QTcF (ΔΔQTcF)
Time frame: Up to Day 13
Number of participants with non-serious adverse events (AEs)
Time frame: Up to approximately 17 weeks
Number of participants with Serious AEs (SAEs)
Time frame: Up to approximately 17 weeks
Number of participants with AEs leading to study intervention discontinuation
Time frame: Up to approximately 17 weeks
Number of participants with vital sign abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with clinical laboratory assessment abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with 12-lead ECG abnormalities
Time frame: Up to approximately 17 weeks
Number of participants with physical examination abnormalities
Time frame: Up to approximately 17 weeks
Maximum observed concentration (Cmax)
Time frame: Up to Day 13
Time of maximum observed concentration (Tmax)
Time frame: Up to Day 13
Area under the concentration-time curve in 1 dosing interval (AUC[TAU])
Time frame: Up to Day 13