Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters
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.
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in healthy male and female volunteers does not increase QTc interval compared to placebo. [ Time Frame: January to April 2009 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||May 2009|
|Primary Completion Date:||April 2009 (Final data collection date for primary outcome measure)|
2-10 mg prucalopride
Other Name: Resolor
Placebo Comparator: 2
400 mg moxifloxacin (Group 2a)
Other Name: AveloxDrug: placebo
placebo (Group 2b)
Other Name: Placebo
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).