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Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers

NCT00856869 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2009-03-06

No results posted yet for this study

Summary

The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh \[CTP\] class A-C), NASH, young and elderly healthy males, and young and elderly healthy females, to assess the effects of liver dysfunction, gender, age and prandial intestinal hyperaemia on the clearance of NRL972. In addition, the study was to provide information on the safety and tolerability of repeated intravenous doses of NRL972 in these populations.

Conditions

Interventions

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

DRUG

NRL972

Single 2 mg intravenous injection administered once after an overnight fast and once after a standard meal

Sponsors & Collaborators

Principal Investigators

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

  • Hans-Jürgen Gruss, MD · Norgine

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-02-28
Completion
2005-04-30

Countries

  • Bulgaria

Study Locations

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Entities

Diseases
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 NCT00856869 on ClinicalTrials.gov