The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
QUADRUPLE
Enrollment
59
Ppd Development, Llc
Austin, Texas, United States
Difference from placebo of BMS-791325 in time-matched change from baseline (Day -1 on the study) to Day 3 of each period (ΔΔQTcF) at postdose extraction times for the QTcF
Time frame: Approximately 28 days
ΔΔHR, ΔΔPR, ΔΔQRS, ΔΔQT
Difference from placebo in time-matched change from baseline (Day -1) to Day 3 at postdose extraction times in the ECG-derived RR or HR and other ECG intervals (PR, QRS, QT). QT is the unadjusted QT interval
Time frame: Approximately 28 days
Number and percent of subjects having a within-period maximum HR, PR, QRS, QT, QTcF, ΔQT and ΔQTcF within prespecified categories
Time frame: Approximately 28 days
Relationship between plasma concentrations of BMS-791325, BMS-794712, and BMS-948158, and the corresponding ΔΔQTcF
Time frame: Approximately 28 days
Maximum observed concentration (Cmax) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Time of maximum observed concentration (Tmax) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Area under the concentration-time curve in one dosing interval (AUC(TAU)) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Apparent total oral clearance (CLT/F) of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Terminal phase plasma half life (T-HALF) of BMS-791325, BMS-794712, and BMS-948158
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Time frame: 43 timepoints up to day 26
AUC(TAU) metabolic ratios of BMS-791325, BMS-794712, and BMS-948158
Time frame: 43 timepoints up to day 26
Incidence of AEs, SAEs, AEs leading to discontinuation and death, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examination, and abnormalities in vital sign measurements exceeding pre-defined thresholds
Adverse event (AEs) Serious adverse event (SAEs)
Time frame: Up to day 28
Difference from placebo of Moxifloxacin in change from baseline (Day -1) to Day 3 at postdose extraction times for the QTcF (ΔΔQTcF)
Time frame: Approximately 28 days