Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

NCT ID: NCT01134185

Last Updated: 2012-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-02-28

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group I

Moderate hepatic impairment (grade B)

Group Type: ACTIVE_COMPARATOR

prucalopride

Intervention Type: DRUG

single oral dose of 2 mg prucalopride

Group II

Severe hepatic impairment (grade C)

Group Type: ACTIVE_COMPARATOR

prucalopride

Intervention Type: DRUG

single oral dose of 2 mg prucalopride

Group III

healthy subjects

Group Type: ACTIVE_COMPARATOR

prucalopride

Intervention Type: DRUG

single dose of 2 mg prucalopride

Interventions

prucalopride

single oral dose of 2 mg prucalopride

Intervention Type: DRUG

prucalopride

single oral dose of 2 mg prucalopride

Intervention Type: DRUG

prucalopride

single dose of 2 mg prucalopride

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Movetis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Moscow, , Russia

Countries

Russia

Other Identifiers

M0001-C103

Identifier Type: -

Identifier Source: org_study_id