NCT01164332

Sensitivity of Alternative NRL972 Detection Methods in Healthy Subjects

Investigation of the Sensitivity of Different Methods to Detect NRL972 in Healthy Volunteers During and After a 2-hour Intravenous Infusion of 10 and 30mg NRL972

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Norgine · Industry
• Sex: All
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The disposition of NRL972 after a 15-second intravenous injection of 2 mg NRL972 is distinctly slower in patients with hepatic cirrhosis and acute hepatitis than in healthy control subjects. NRL972 appears to be a suitable investigational marker of hepatic transporter clearance dysfunction. Although the pharmacokinetics of NRL972 provide a reliable differentiation between subject groups, this approach relies on precisely timed sampling of venous blood, cautious preparation, handling and on-site storage of plasma samples, the transfer of samples to a central laboratory for analysis, and the availability of a validated assay procedure. For these reasons, there is interest in developing and validating alternative methods for determining the concentration of NRL972 in venous blood. Two such methods have been developed to date, but their utility in determining NRL972 pharmacokinetics has yet to be established.

Conditions

• Cirrhosis

Interventions

Type	Name	Description
OTHER	NRL972	Two-hour intravenous infusion of 5 and 15 mg per hour

Timeline

• Start date: 2010-07-01
• Primary completion: 2010-11-01
• Completion: 2011-11-01
• First posted: 2010-07-16
• Last updated: 2015-06-10

Locations

1 site across 1 country: Hungary