Trial intelligence / Profile preview

NRL972 Pharmacokinetics in Healthy Volunteers and Patients with Liver Disease

NCT00856869Phase 2

Key facts

Status: Completed
Start: Aug 2004
Primary completion: Feb 2005
Countries: 1
Sponsor: Norgine
Modality: Small Molecules

Drugs: fluorescein lisicol
Conditions: Liver cirrhosis (LC)Nonalcoholic steatohepatitis (NASH)

Overview

Phase 2, open-label trial of fluorescein lisicol in Liver cirrhosis (LC) and Nonalcoholic steatohepatitis (NASH) (7 arms), sponsored by Norgine. Primary endpoint: Clearance of NRL972. Started Aug 2004; status: completed.

Design

7 arms

Study design: Non-randomizedOpen-label

Healthy young males
Healthy young males receiving NRL972
Healthy elderly males
Healthy elderly males receiving NRL972
Healthy young females
Healthy young females receiving NRL972
Healthy elderly females
Healthy elderly females receiving NRL972
Patients with presumed NASH
Patients with NASH receiving NRL972
Patients with hepatic cirrhosis CTP-class A
Patients with cirrhosis CTP-A receiving NRL972

1 more in the full profile.

Who it enrols

Healthy volunteers (18-40 or >60 years) and patients with stable compensated liver cirrhosis or NASH (18-75 years). Excludes patients with biliary cirrhosis, liver transplant, significant bleeding, or severe comorbidities.

Endpoints

Primary

Clearance of NRL972Up to 4 hours post administration

Secondary

Adverse events and changes in physical findingsUp to 4 hours post-dosing
Effects on vital signsUp to 4 hours post-dosing
Effects on electrocardiogramUp to 4 hours post-dosing
Changes in haematology, clinical chemistry, urinalysisUp to 4 hours post-dosing

Beyond the preview

Go deeper on NCT00856869.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00856869.