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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: safinamide

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Kiel, Germany
    • CRS Clinical Research Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm 1; subjects with mild hepatic impairment	Drug: safinamide; single dose of 50mg safinamide on Day 1
EXPERIMENTAL: Arm 2; subjects with moderate hepatic impairment	Drug: safinamide; single dose of 50mg safinamide on Day 1
EXPERIMENTAL: Arm 3; matched subjects with normal hepatic function	Drug: safinamide; single dose of 50mg safinamide on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of safinamide after single dose administration (Cmax)	10 days
Pharmacokinetics of safinamide after single dose administration (AUC)	10 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Pharmacokinetics of safinamide metabolite NW1689 (AUC)	10 days

Collaborators and Investigators

• Sponsor: Newron Pharmaceuticals SPA

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (ACTUAL): October 1, 2009

Study Registration Dates

• First Submitted: December 3, 2009
• First Submitted That Met QC Criteria: December 4, 2009
• First Posted (ESTIMATE): December 7, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 27, 2013
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Hepatic impairment; Liver diseases; To Investigate Pharmacokinetics of Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Healthy Subjects With Normal Hepatic Function
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 28696