Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

• Status: Completed
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single centre, open-label phase I trial to investigate the effects of moderate to severe hepatic impairment on the pharmacokinetics of prucalopride in comparison with healthy volunteers. Furthermore the short-term safety and tolerability of a single dose of prucalopride will be assessed.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Movetis
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• Main inclusion criteria for hepatic impairment subjects:

• Moderate (Grade B) or severe (Grade C) chronic hepatic impairment according to Child-Pugh classification; Hepatic impairment must be stable, both clinically and biochemically;

• Within the normal range of body height and weight on the basis of the Body Mass Index.

• Main inclusion criteria for healthy subjects:

• Matching on sex, age and weight(BMI based).

Exclusion Criteria:

• History or suspicion of barbiturate, amphetamine or narcotic abuse; Suspicion of current alcohol abuse;

• Clinical suspicion or laboratory evidence of unstable hepatic impairment or acute liver injury;

• Clinically relevant renal disease as judged by the investigator.