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

NCT01027169 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2013-03-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Newron Pharmaceuticals SPA

    lead INDUSTRY

Principal Investigators

  • Atef Halabi, MD · CRS Clinical Research Services Kiel GmbH

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2009-10-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01027169 on ClinicalTrials.gov