NCT01674166

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

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Movetis · Industry
• Sex: —
• Age: 4 Years – 12 Years
• Healthy volunteers: —

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

Detailed 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.

Conditions

• Constipation

Interventions

Type	Name	Description
DRUG	prucalopride	single dose 0.03 mg/kg prucalopride open label

Timeline

• Start date: 1998-11-01
• Primary completion: 1999-05-01
• Completion: 1999-05-01
• First posted: 2012-08-28
• Last updated: 2012-08-28