Clinical trial NCT01027169: A Study to Assess the Effect of Hepatic Impairment on Safinamide Pharmacokinetics
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Keywords: 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
Lead sponsor: Newron Pharmaceuticals SPA
Sponsor class: INDUSTRY
First posted: 2009-12-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: Pharmacokinetics of safinamide after single dose administration (Cmax)
timeFrame: 10 days
measure: Pharmacokinetics of safinamide after single dose administration (AUC)
timeFrame: 10 days
Secondary outcomes:
measure: Safety and tolerability after single dose administration of safinamide (Adverse Events)
timeFrame: 12 days
measure: Pharmacokinetics of safinamide metabolite NW1153 (Cmax)
timeFrame: 10 days
measure: Pharmacokinetics of safinamide metabolite NW1153 (AUC)
timeFrame: 10 days
measure: Pharmacokinetics of safinamide metabolite NW1689 (Cmax)
timeFrame: 10 days
measure: Pharmacokinetics of safinamide metabolite NW1689 (AUC)
timeFrame: 10 days
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
Study officials:
affiliation: CRS Clinical Research Services Kiel GmbH
name: Atef Halabi, MD
role: PRINCIPAL_INVESTIGATOR
References: