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

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