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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01027169

Enrollment

Registered

2009-12-07

Start date

2009-04-30

Completion date

Unknown

Last updated

2013-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGsafinamide

single dose of 50mg safinamide on Day 1

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics of safinamide after single dose administration (Cmax)	10 days
Pharmacokinetics of safinamide after single dose administration (AUC)	10 days

Secondary

Measure	Time frame
Pharmacokinetics of safinamide metabolite NW1153 (AUC)	10 days
Safety and tolerability after single dose administration of safinamide (Adverse Events)	12 days
Pharmacokinetics of safinamide metabolite NW1689 (AUC)	10 days
Pharmacokinetics of safinamide metabolite NW1689 (Cmax)	10 days
Pharmacokinetics of safinamide metabolite NW1153 (Cmax)	10 days

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026