NCT01134185

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

April 19, 2012

Status Verified

October 1, 2011

Enrollment Period

9 months

First QC Date

May 21, 2010

Last Update Submit

April 17, 2012

Conditions

Hepatic Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    Evaluation of prucalopride in blood immediately before and at 17 timepoints post dosing and in urine at 8 collection time points.

    6 days

Secondary Outcomes (1)

  • Safety and tolerability

    6 days

Study Arms (3)

Group I

ACTIVE COMPARATOR

Moderate hepatic impairment (grade B)

Drug: prucalopride

Group II

ACTIVE COMPARATOR

Severe hepatic impairment (grade C)

Drug: prucalopride

Group III

ACTIVE COMPARATOR

healthy subjects

Drug: prucalopride

Interventions

prucaloprideDRUG

single oral dose of 2 mg prucalopride

Group I

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Moscow, Russia

Location

MeSH Terms

Interventions

prucalopride

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2010

First Posted

May 31, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

April 19, 2012

Record last verified: 2011-10

Locations

RU(1)