Effects of Therapeutic and Supratherapeutic Doses of Siponimod (BAF312) on Cardiac Repolarization in Healthy Subjects.

@article{ShakeriNejad2015EffectsOT,
  title={Effects of Therapeutic and Supratherapeutic Doses of Siponimod (BAF312) on Cardiac Repolarization in Healthy Subjects.},
  author={Kasra Shakeri-Nejad and Vassilios Aslanis and Uday Kiran Veldandi and Louise Mooney and Nicole Pezous and Bruno Brendani and Axel Juan and Mark J. Allison and Robert G Perry and Eric Legangneux},
  journal={Clinical therapeutics},
  year={2015},
  volume={37 11},
  pages={2489-2505.e2}
}
PURPOSE 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. METHODS The study was a randomized, double-blind, parallel-group, placebo… CONTINUE READING