Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters
Status:
Completed
Trial end date:
2009-05-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Movetis
Treatments:
Moxifloxacin Norgestimate, ethinyl estradiol drug combination Prucalopride