Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

Hepatic Impairment Clinical Trial

— HI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01134185
• Other study ID #: M0001-C103
• Status: Completed
• Phase: Phase 1
• First received: May 21, 2010
• Last updated: April 17, 2012
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: October 2011
• Source: Movetis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• prucalopride
single oral dose of 2 mg prucalopride
• prucalopride
single oral dose of 2 mg prucalopride
• prucalopride
single dose of 2 mg prucalopride

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Movetis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics	Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.	6 days	No
Secondary	Safety and tolerability	Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.	6 days	No