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

• Status: Completed
• Trial end date: 1999-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• Subjects with a confirmed diagnosis of FFR, defined as a minimum 2-month history of faecal impaction, plus at least one of the following:

• < 3 bowel movements per week at the toilet;

• A history of soiling;

• Male and female subjects ≥ 4 to ≤ 12 years of age, with a Tanner stage 1 of 2 or less;

• Weight-height proportionality for age within the 5th and 95th percentile;

• Written informed consent, signed by the subject's legal guardian and by the investigator, and;

• Subject assent documented in the form of a note-to-file in the subject's source documentation.

Exclusion Criteria:

• Requirement for any medication during the period of the trial;

• Evidence by examination or laboratory tests of abnormal growth;

• An abnormal neurologic examination;

• Cystic fibrosis;

• History of, or current anorectal malformations;

• Diagnosed chromosomal abnormalities (e.g., Down's Syndrome);

• Disease state or surgery known to significantly affect the gastrointestinal absorption of drugs, or the assessment of the trial drug's effect;

• Any history, clinical and/or biochemical evidence of clinically significant renal or liver disease or cirrhosis;

• Clinically significant anaemia;

• Use of any investigational drug within the 4-week period prior to administration of trial medication.