NCT00856869

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

A Study in Healthy Volunteers and Patients With Liver Cirrhosis and Non-Alcoholic Steatohepatitis (NASH) to Assess the Effects of Age, Gender, Chronic Liver Disease, and Prandial Effects on the Clearance of Cholyl-Lysyl-Fluorescein (NRL972) an an in-Vivo Marker of Liver Function in Man.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

• Hepatic Cirrhosis
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-08-01
• Primary completion: 2005-02-01
• Completion: 2005-04-01
• First posted: 2009-03-06
• Last updated: 2009-03-06

Locations

1 site across 1 country: Bulgaria