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

Phase 1

Completed

• Conditions: Hepatic Impairment
• Interventions: Drug: safinamide

• Registration Number: NCT01027169
• Lead Sponsor: Newron Pharmaceuticals SPA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-10
• Study First Submitted: 2009-12-03
• Study First Submitted QC: 2009-12-04
• Study First Posted: 2009-12-07
• Status Verified: 2011-08
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	safinamide	subjects with mild hepatic impairment
Arm 2	safinamide	subjects with moderate hepatic impairment
Arm 3	safinamide	matched subjects with normal hepatic function

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of safinamide after single dose administration (Cmax)	10 days
Pharmacokinetics of safinamide after single dose administration (AUC)	10 days

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics of safinamide metabolite NW1689 (AUC)	10 days
Safety and tolerability after single dose administration of safinamide (Adverse Events)	12 days
Pharmacokinetics of safinamide metabolite NW1153 (Cmax)	10 days
Pharmacokinetics of safinamide metabolite NW1153 (AUC)	10 days
Pharmacokinetics of safinamide metabolite NW1689 (Cmax)	10 days

Trial Locations

Locations (1)

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany