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

NCT ID: NCT01027169

Last Updated: 2013-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30

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.

Conditions

Hepatic Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Arm 1

subjects with mild hepatic impairment

Group Type: EXPERIMENTAL

safinamide

Intervention Type: DRUG

single dose of 50mg safinamide on Day 1

Arm 2

subjects with moderate hepatic impairment

Group Type: EXPERIMENTAL

safinamide

Intervention Type: DRUG

single dose of 50mg safinamide on Day 1

Arm 3

matched subjects with normal hepatic function

Group Type: EXPERIMENTAL

safinamide

Intervention Type: DRUG

single dose of 50mg safinamide on Day 1

Interventions

safinamide

single dose of 50mg safinamide on Day 1

Intervention Type: DRUG

safinamide

single dose of 50mg safinamide on Day 1

Intervention Type: DRUG

safinamide

single dose of 50mg safinamide on Day 1

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atef Halabi, MD

Role: PRINCIPAL_INVESTIGATOR

CRS Clinical Research Services Kiel GmbH

Locations

CRS Clinical Research Services Kiel GmbH

Kiel, , Germany

Countries

Germany

Other Identifiers

28696

Identifier Type: -

Identifier Source: org_study_id