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

Newron Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Hepatic Impairment

Treatments: Drug: safinamide

Study type: Interventional

Funder types: Industry

Identifiers

NCT01027169

28696

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Arm 1

Experimental group

Description:

subjects with mild hepatic impairment

Treatment:

Drug: safinamide

Arm 2

Experimental group

Description:

subjects with moderate hepatic impairment

Treatment:

Drug: safinamide

Arm 3

Experimental group

Description:

matched subjects with normal hepatic function

Treatment:

Drug: safinamide