This is a study to investigate the experimental medication BMS-986165 in healthy participants in order to study the effects it has on electrocardiogram results.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
84
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
PRA Health Sciences
Lenexa, Kansas, United States
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
Time frame: From baseline to 5 days
Placebo-corrected change from baseline in corrected (Fridericia) QT Interval (QTcF) for moxifloxacin as determined by 12-lead ECG
Time frame: From baseline to 5 days
Heart rate (HR) as determined by 12-lead ECG
Time frame: 5 days
QRS as determined by 12-lead ECG
Time frame: 5 days
PR as determined by 12-lead ECG
Time frame: 5 days
Change from baseline in corrected (Fridericia) QT Interval (QTcF) as determined by 12-lead ECG
Time frame: From baseline to 5 days
Incidence of participant abnormalities in vital signs, clinical laboratory tests, safety 12-lead ECGs, and physical examinations
Time frame: Up to 28 days
Incidence of adverse events (AE)
Time frame: Up to 28 days
Incidence of serious adverse events (SAE)
Time frame: Up to 28 days
Maximum observed concentration (Cmax) as determined by plasma concentration
Time frame: 5 days
Time of maximum observed concentration (Tmax) as determined by plasma concentration
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Time frame: 5 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] as determined by plasma concentration
Time frame: 5 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] as determined by plasma concentration
Time frame: 5 days