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Evaluation of Prucalopride in Subjects With Moderate and Severe Hepatic Impairment

NCT01134185 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-04-19

No results posted yet for this study

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.

Conditions

  • Hepatic Impairment

Interventions

DRUG

prucalopride

single oral dose of 2 mg prucalopride

DRUG

prucalopride

single oral dose of 2 mg prucalopride

DRUG

prucalopride

single dose of 2 mg prucalopride

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-02-28
Completion
2011-02-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01134185 on ClinicalTrials.gov