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Clearance of NRL972 in Patients With Cirrhosis and in Healthy Volunteers

NCT00856713 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2009-03-06

No results posted yet for this study

Summary

A study in healthy volunteers and patients with liver cirrhosis to assess the effects of age, gender, and stable liver disease on the clearance of cholyl-lysyl-fluorescein (NRL972)

Conditions

  • Hepatic Cirrhosis

Interventions

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

DRUG

NRL972

Single intravenous dose of 2 mg NRL972

Sponsors & Collaborators

Principal Investigators

  • Hans-Jürgen Gruss, MD · Norgine

  • Zahariy Krastev, MD · St Ivan Rilski's University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-08-31

Countries

  • Bulgaria

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 NCT00856713 on ClinicalTrials.gov