Safety Study of Prucalopride in Healthy Volunteers

Healthy Clinical Trial

Official title: A Double-Blind, Placebo-Controlled, Two-Way Cross-Over in Healthy Volunteers, to Evaluate the Pharmacokinetics, Tolerability and Cardiac Safety of Prucalopride at Steady-State

Status Completed

Clinical Trial Summary

In this study healthy volunteers received increasing doses of prucalopride to study the tolerability and cardiac safety of prucalopride. The study hypothesis was that prucalopride at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in healthy volunteers.

Clinical Trial Description

Single-centre, double-blind, placebo-controlled, cross-over study in 33 healthy volunteers with 2 sessions. Each session consisted of a run-in day for baseline assessments, 8 treatment days and 5 additional days for followup assessments. Subjects were randomised to start with either the prucalopride or placebo session. The prucalopride dose was consecutively escalated in 2 mg steps per day, starting from 2 mg up to 10 mg once daily If a subject did not tolerate the 10- or 8-mg dose, 1 step back in the dosage scheme was allowed, from 10 to 8 mg on Day 6, or from 8 to 6 mg on Day 5. Subjects with intolerance for doses of less than 6 mg, were withdrawn from the study. Repeated dosing (6, 8 or 10 mg) was continued once daily until Day 8, to achieve steady-state. During placebo, the number of placebo tablets was consecutively escalated in an identical way as described for prucalopride. Between the 2 sessions, there was a washout period of 14 to 21 days, to avoid any carry-over effect. ;

Study Design

N/A

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT00793429
• Study type: Interventional
• Source: Movetis
• Status: Completed
• Phase: Phase 1