Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters

Summary

This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised study, stratified by gender and with a hybrid crossover group design, to compare treatment with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included as a positive control in terms of the effect on cardiac repolarisation. Study hypothesis: Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers will not increase QTc interval compared to placebo.

Timeline

Start

2009-01

Primary completion

2009-04

Completion

2009-05

Publications

• Mendzelevski B, Ausma J, Chanter DO, Robinson P, Kerstens R, Vandeplassche L, Camm J. Assessment of the cardiac safety of prucalopride in healthy volunteers: a randomized, double-blind, placebo- and positive-controlled thorough QT study. Br J Clin Pharmacol. 2012 Feb;73(2):203-9. doi: 10.1111/j.1365-2125.2011.04088.x.

Drugs

Indications