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Evaluation of the Pharmacokinetics of Ulimorelin in Subjects With Hepatic Impairment and Healthy Subjects

NCT01405599 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-10-16

No results posted yet for this study

Summary

Evaluation of the effect of hepatic impairment on the pharmacokinetics of ulimorelin after a single intravenous (IV) dose in order to identify potential patients at risks in terms of severity of hepatic dysfunction and to determine whether their dosage should be adjusted.

Conditions

  • Digestive System Disorders

Interventions

DRUG

Ulimorelin

Single dose of 480 micrograms/kg administered as a 30 minute intravenous infusion

Sponsors & Collaborators

Principal Investigators

  • Maria Tomas, PhD · Norgine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2011-10-31
Completion
2011-10-31

Countries

  • Slovakia

Study Locations

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Entities

Companies

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 NCT01405599 on ClinicalTrials.gov