Constipation Clinical Trial
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
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.
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).
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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