drugset / Trial / NCT00856869
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
Non-randomizedParallel-groupOpen-labelDiagnostic
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.
Timeline
- Start
- 2004-08
- Primary completion
- 2005-02
- Completion
- 2005-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | FLUORESCEIN LISICOL | Diagnostic / imaging agent | 2 mg | Intravenous |