Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention

Constipation Clinical Trial

Official title: A Single-dose Pharmacokinetic Trial of 0.03 mg/kg R108512 Solution in Paediatric Subjects, Aged >= 4 to <= 12 Years With Functional Faecal Retention (FFR).

Status Completed

Clinical Trial Summary

The purpose of this study is characterize the pharmacokinetics of a single oral dose of 0.03 mg/kg prucalopride in paediatric subjects aged >= 4 to <= 12 years with functional faecal retention.

Hypothesis:

Pharmacokinetic profile of prucalopride in paediatric subjects is expected to resemble the adult pharmacokinetic profile

Clinical Trial Description

This is a multicentre, open-label, single-dose pharmacokinetic trial. A minimum of 24 paediatric subjects (aged ≥ 4 to ≤ 12 years) with functional faecal retention (FFR) were administered a single dose of prucalopride in oral solution.

All subjects who qualified to enter the trial received a single dose of 0.03 mg/kg prucalopride oral solution at Hour 0 on Day 1. One blood sample was drawn prior to dosing, and 13 samples were drawn over the 72-hour interval following the single dose or prucalopride. Urine was collected quantitatively for the first 24 hours. Plasma prepared from blood samples and urine samples were assayed for prucalopride concentrations. Safety was monitored over the 72-hour interval following the dose of trial medication. ;

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

• NCT number: NCT01674166
• Study type: Interventional
• Source: Movetis
• Status: Completed
• Phase: Phase 1
• Start date: November 1998
• Completion date: May 1999