NCT00794716

PK of NRL972 in Patients with Nonalcoholic Steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD)

Prospective Single-centre, Open-label Study to Assess the Pharmacokinetics of Cholyl-lysl-fluorescein (NRL972) in Patients with Clinical Evidence for NAFLD: Supporting the Disease Staging Into Fatty Liver Disease Versus NASH

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 125 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the predictive value of NRL972 pharmacokinetics in the diagnosis of steatohepatitis using fatty liver disease as the comparator group. In addition, the sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic tool will be compared to results from the standard laboratory tests, elastography, tests of metabolic markers and serum fibrosis markers frequently used in the evaluation of clinically predicted NAFLD patients. Patients will be included if they have clinical evidence of fatty liver disease and have been referred to the clinic for a diagnostic work-up, including a liver biopsy, blood tests and scans of the liver.

Detailed description

The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 after a 15-second intravenous (i.v.) injection of 2 mg NRL972 against the diagnostic assessment based on liver biopsy in patients with clinically suspected NAFLD. A particular focus was to separate simple fatty liver disease (non-NASH) from non-alcoholic steatohepatitis (NASH) with or without cirrhosis (defined as advanced fibrosis: ≥F3) in a population likely to present with NAFLD. The study evaluated the predictive value of NRL972 pharmacokinetics in the diagnosis of NASH using fatty liver disease (non-NASH) as the comparator group in a population of clinically suspected NAFLD patients based on histological evaluation. The sensitivity and specificity of NRL972 pharmacokinetics as a diagnostic was compared to that of results from the standard laboratory tests, clinical features, elastography assessments for liver stiffness and tests of metabolic markers, serum fibrosis markers and established disease scores frequently used in the evaluation of NAFLD. The study also provided information on the safety and tolerability of i.v. doses of NRL972 under these conditions.

Conditions

• Non-Alcoholic Fatty Liver Disease
• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	NRL972	Single dose of 2 mg NRL972 administered intravenously. Total volume 5mL.

Timeline

• Start date: 2008-06-01
• Primary completion: 2010-03-01
• Completion: 2011-11-01
• First posted: 2008-11-20
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study