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

Hepatic Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027169
• Other study ID #: 28696
• Status: Completed
• Phase: Phase 1
• First received: December 3, 2009
• Last updated: March 27, 2013
• Start date: April 2009

Study information

• Verified date: August 2011
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Hepatically impaired subjects - Subjects with liver cirrhosis and different degrees of impaired hepatic function: mild and moderate impaired hepatic function (Grade A, or B according to Child-Pugh classification)

• Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, ECG and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to the dosing

• All subject have given written informed consent before any study-related activities are carried out

Exclusion Criteria:

• Any clinically relevant disease or condition, which in the Investigator's opinion would exclude the subject from the study

• Diseases or surgeries of the gastrointestinal tract, which could influence the gastro-intestinal absorption and/or motility

• Hepatically impaired subjects - Subjects with primary biliary liver cirrhosis, hepatic encephalopathy grade III and IV, sepsis or spontaneous bacterial peritonitis, gastrointestinal bleeding within one month before the study, esophagus varices > grade II, acute hepatic failure of any aetiology, portosystemic shunt, renal impairment (creatinine clearance < 50 mL/min calculated by use of Cockroft Gault formula)

• Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to the drug administration, or within six times the elimination half-life, whichever is longest, except combined oral contraceptives and occasional use of paracetamol or ibuprofen within 14 days before study drug administration

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• safinamide
single dose of 50mg safinamide on Day 1
• safinamide
single dose of 50mg safinamide on Day 1
• safinamide
single dose of 50mg safinamide on Day 1

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of safinamide after single dose administration (Cmax)		10 days	No
Primary	Pharmacokinetics of safinamide after single dose administration (AUC)		10 days	No
Secondary	Safety and tolerability after single dose administration of safinamide (Adverse Events)		12 days	No
Secondary	Pharmacokinetics of safinamide metabolite NW1153 (Cmax)		10 days	No
Secondary	Pharmacokinetics of safinamide metabolite NW1153 (AUC)		10 days	No
Secondary	Pharmacokinetics of safinamide metabolite NW1689 (Cmax)		10 days	No
Secondary	Pharmacokinetics of safinamide metabolite NW1689 (AUC)		10 days	No