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. Issue 1 (25th September 2013)

• Record Type: Journal Article
• Authors: Kosoglou, Teddy; Hunt, Thomas L.; Xuan, Fengjuan; Kumar, Bharath; Statkevich, Paul; Hanson, Mary E.; Cutler, David L.
• Is Part Of: Clinical pharmacology in drug development. Volume 3:Issue 1(2014:Jan./Feb.)
• Page Start: 18
• Page End: 24
• Publication Date: 2013-09-25
• Subjects: Drugs -- Testing -- Periodicals; Drug development -- Periodicals; Clinical pharmacology -- Periodicals; 615.580724
• DOI: 10.1002/cpdd.49
• Languages: English
• ISSNs: 2160-7648

Abstract

<abstract abstract-type="main" xml:lang="en"> <title>Abstract</title> <sec id="cpdd49-sec-0001" sec-type="section"> <p>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 &lt;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 &gt;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.</p> </sec> </abstract>