NCT00903747

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

A Phase I Thorough QT/QTc Study To Evaluate The Effect of Therapeutic and Supratherapeutic Multiple Doses of Prucalopride on Cardiac Repolarisation in Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Movetis · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are planned to be randomised. Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will receive moxifloxacin, and Group 2b will receive placebo. On Day 5 (steady-state level is reached), a full ECG assessment day will be performed, enabling the comparison of prucalopride 2 mg with placebo. Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a day up to 5 tablets. On Day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another ECG assessment day will be performed, enabling a comparison of prucalopride 10 mg with placebo. Group 2b will receive a single dose of moxifloxacin on Day 15. All subjects will be discharged on Day 16. Subjects will remain in the CRU throughout the treatment period. All subjects will return for a follow-up visit on Day 30 (± 1 week) (approximately 14 days after the last dose).

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	2-10 mg prucalopride
DRUG	moxifloxacin	400 mg moxifloxacin (Group 2a)
DRUG	placebo	placebo (Group 2b)

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2009-05-18
• Last updated: 2009-05-18