Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment (HI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01134185
Recruitment Status : Completed
First Posted : May 31, 2010
Last Update Posted : April 19, 2012
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: prucalopride Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Arm Intervention/treatment
Active Comparator: Group I
Moderate hepatic impairment (grade B)
Drug: prucalopride
single oral dose of 2 mg prucalopride

Active Comparator: Group II
Severe hepatic impairment (grade C)
Drug: prucalopride
single oral dose of 2 mg prucalopride

Active Comparator: Group III
healthy subjects
Drug: prucalopride
single dose of 2 mg prucalopride

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 6 days ]
    Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 6 days ]
    Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01134185

Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators

Responsible Party: Movetis Identifier: NCT01134185     History of Changes
Other Study ID Numbers: M0001-C103
First Posted: May 31, 2010    Key Record Dates
Last Update Posted: April 19, 2012
Last Verified: October 2011

Keywords provided by Movetis:
Two groups of 8 hepatically impaired subjects, one group of 8 matched healthy subjects

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases