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2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-27 @ 11:11 PM
Study NCT ID:
NCT01674166
Status:
COMPLETED
Last Update Posted:
2012-08-28
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose Pharmacokinetics of Prucalopride in Paediatric Subjects, With Functional Faecal Retention
Sponsor:
Movetis
Organization:
Study Overview
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
Status Verified Date:
2012-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: