Key result
BMS-820836 up to 4 mg daily does not prolong the QT interval in healthy subjects.
Why the study?
BMS-820836 causes dose-dependent heart rate increases, necessitating comparison of different QT interval correction methods in a thorough QT study.
Does BMS-820836 prolong the QT interval in healthy subjects, and which QT correction method is optimal for drugs that increase heart rate?
Comparison
BMS-820836 2 mg or 4 mg once daily vs encapsulated moxifloxacin 400 mg or matching placebo
Design
Randomized controlled trial with nested-crossover design and matching placebo
Follow-up
14 days
Authors
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Supports cardiac safety of BMS-820836 without QT monitoring; validates QTcI as optimal correction for heart rate-increasing drugs.
RCT (n=180)
Does BMS-820836 prolong the QT interval in healthy subjects, and which QT correction method is optimal for drugs that increase heart rate?
BMS-820836 does not prolong the QT interval at therapeutic or supratherapeutic doses, and QTcI appears to be the optimal correction method for drugs that increase heart rate.
Zheng et al. (2015) conducted an RCT in Healthy subjects (n=180). BMS-820836 vs. Placebo and moxifloxacin was evaluated on QT interval prolongation (using QTcI). BMS-820836 at doses up to 4 mg once daily for 14 days was not associated with prolongation of the QT interval in healthy subjects.
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