NCT01027169

A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics

An Open-label, Parallel-group, Single Centre, Single Oral Dose Study to Investigate the Pharmacokinetics of 50 mg Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Matched Subjects With Normal Hepatic Function

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Newron Pharmaceuticals SPA · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	safinamide	single dose of 50mg safinamide on Day 1
DRUG	safinamide	single dose of 50mg safinamide on Day 1
DRUG	safinamide	single dose of 50mg safinamide on Day 1

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-10-01
• First posted: 2009-12-07
• Last updated: 2013-03-29

Locations

1 site across 1 country: Germany