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Effect of the thrombin receptor antagonist (PAR-1) vorapaxar on QT/QTc interval in healthy volunteers: A randomized, placebo- and positive-controlled, parallel group trial
Ist Teil von
Clinical pharmacology in drug development, 2014-01, Vol.3 (1), p.18-24
Ort / Verlag
United States: Blackwell Publishing Ltd
Erscheinungsjahr
2014
Link zum Volltext
Quelle
Wiley Online Library Journals Frontfile Complete
Beschreibungen/Notizen
In a randomized, double‐blind (vorapaxar and placebo), placebo‐ and positive‐controlled (moxifloxacin 400 mg) parallel group study, the effect of single‐dose vorapaxar 120 mg on QT/QTc interval was assessed in 120 adults 18–50 years. Twelve‐lead digital ECGs were obtained in triplicate using Mortara H12+ Holter monitors at 9 timepoints over 24 hours. If the largest upper bound of the 95% one‐sided CI for the mean difference in QTcF between vorapaxar and placebo was <10 milliseconds, vorapaxar was considered to have no potential for QT/QTc prolongation of regulatory concern. Vorapaxar was well‐tolerated. The lower bound of the 95% CI for the difference in QTcF between moxifloxacin and placebo was >5 milliseconds, confirming study sensitivity. Vorapaxar had no significant effect on QTcF. At all timepoints the upper 95% CI for the mean difference between placebo and vorapaxar was ≤3.8 milliseconds (mean difference ≤1.0 milliseconds). Vorapaxar does not prolong the QT/QTc interval in healthy subjects.