Clinical therapeutics
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Clinical therapeutics · Nov 2015
Randomized Controlled TrialEffects of Therapeutic and Supratherapeutic Doses of Siponimod (BAF312) on Cardiac Repolarization in Healthy Subjects.
The International Conference on Harmonisation E14 guideline mandates an intensive cardiac safety evaluation in a clinical thorough QT study, typically in healthy subjects, for all new non-antiarrhythmic drugs with systemic bioavailability. This thorough QT study investigated the effects of therapeutic (2 mg) and supratherapeutic (10 mg) doses of siponimod (BAF312) on cardiac repolarization in healthy subjects. ⋯ The findings provide evidence that siponimod is not associated with a significant arrhythmogenic potential related to QT prolongation.