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.
Clin Pharmacol Drug Dev
; 3(1): 18-24, 2014 Jan.
Article
in En
| MEDLINE
| ID: mdl-27128226
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Type of study:
Clinical_trials
Language:
En
Journal:
Clin Pharmacol Drug Dev
Year:
2014
Document type:
Article