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

Sponsor

Newron Pharmaceuticals SPA (Industry)

Overall Status

Completed

CT.gov ID

NCT01027169

Collaborator

(none)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment	Drug: safinamide Drug: safinamide Drug: safinamide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Oct 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pharmacokinetics of safinamide after single dose administration (Cmax) [10 days]
Pharmacokinetics of safinamide after single dose administration (AUC) [10 days]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CRS Clinical Research Services Kiel GmbH	Kiel		Germany

Sponsors and Collaborators

Newron Pharmaceuticals SPA

Investigators

Principal Investigator: Atef Halabi, MD, CRS Clinical Research Services Kiel GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Newron Pharmaceuticals SPA

ClinicalTrials.gov Identifier:

NCT01027169

Other Study ID Numbers:

28696

First Posted:

Dec 7, 2009

Last Update Posted:

Mar 29, 2013

Last Verified:

Aug 1, 2011

Keywords provided by Newron Pharmaceuticals SPA

Hepatic impairment

Liver diseases

Pharmacokinetics

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:

Liver Diseases

Study Results

No Results Posted as of Mar 29, 2013