NCT01433458

Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Subjects

A Single-dose, Open-label Parallel Study to Assess the Pharmacokinetics of RLX030 in Subjects With Mild, Moderate and Severe Hepatic Impairment Compared to Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study will assess the pharmacokinetics of RLX030 during and after administration in subjects with mild to severe hepatic impairment and matched healthy control subjects. 20 to 24 patients and 20 to 24 healthy subjects will be enrolled.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	RLX030A	RLX030 is administered as a continuous 24 hour infusion

Timeline

• Start date: 2011-07-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-09-14
• Last updated: 2020-12-21

Locations

2 sites across 2 countries: Germany, Russia