Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

Evaluation of Pharmacokinetics, Safety and Tolerability of a Single Dose of Prucalopride, in Subjects With Moderate and Severe Hepatic Impairment, in Comparison With Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01134185

Acronym

Enrollment

Registered

2010-05-31

Start date

2010-05-31

Completion date

2011-02-28

Last updated

2012-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Impairment

Keywords

Two groups of 8 hepatically impaired subjects, one group of 8 matched healthy subjects

Brief 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.

Detailed description

In this phase I trial two groups of 6 to 8 hepatically impaired subjects will be evaluated. The first group are the moderate hepatic impairment (Grade B) subjects and the second group the severe hepatic impairment (grade C) subjects. Subjects for both groups will be recruited and treated in parallel. After all subjects with hepatic impairment completed the treatment a third group with matching healthy volunteers will be recruited. Eight healthy subjects will be selected matching for age, gender and weight (BMI based). The subjects will receive a single dose of 2 mg prucalopride in the morning after overnight fasting followed by the consumption of a standard breakfast after 2 hours. Pharmacokinetic evaluation of blood samples will be done immediately before and at a specific timepoint up to 120h post-dosing. Urine samples will be taken to determine prucalopride. Adverse events, including serious adverse events, will be reported from signing the Informed Consent until the last visit. Safety blood samples and a urine sample for urinalysis will be taken.

Interventions

DRUGprucalopride

single oral dose of 2 mg prucalopride

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics	6 days	Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.

Secondary

Measure	Time frame	Description
Safety and tolerability	6 days	Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026