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Prucalopride Subjects With Renal Impairment

NCT01674192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2012-08-28

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetics of a single 2 mg oral dose of prucalopride in subjects with various degrees of renal impairment compared with normal renal function and to monitor the safety profile of prucalopride in subjects with renal impairment.

Hypothesis:

Prucalopride might accumulate and exhibit a different pharmacokinetic profile in renally impaired subjects compared with the normal population.

Conditions

Interventions

DRUG

prucalopride

single dose of 2 mg prucalopride

Sponsors & Collaborators

  • Movetis

    lead INDUSTRY

Principal Investigators

  • W. Smith, M.D. · New Orleans Center for Clinical Research, 2820 Canal Street, New Orleans, LA 70119

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-07-31
Primary Completion
1999-08-31
Completion
1999-08-31

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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 NCT01674192 on ClinicalTrials.gov