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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Movetis
ClinicalTrials.gov Identifier:
NCT01134185
First received: May 21, 2010
Last updated: April 17, 2012
Last verified: October 2011
  Purpose

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 Intervention Phase
Hepatic Impairment
Drug: prucalopride
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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

Further study details as provided by Movetis:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.


Secondary Outcome Measures:
  • Safety and tolerability [ Time Frame: 6 days ] [ Designated as safety issue: No ]
    Evaluation of safety parameters by measuring adverse events, safety, blood and urine samples, ECGs, vital signs and physical examinations.


Enrollment: 24
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01134185

Locations
Russian Federation
Moscow, Russian Federation
Sponsors and Collaborators
Movetis
  More Information

No publications provided

Responsible Party: Movetis
ClinicalTrials.gov Identifier: NCT01134185     History of Changes
Other Study ID Numbers: M0001-C103
Study First Received: May 21, 2010
Last Updated: April 17, 2012
Health Authority: Russia: Pharmacological Committee, Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014