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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newron Sweden AB
ClinicalTrials.gov Identifier:
NCT01027169
First received: December 3, 2009
Last updated: March 27, 2013
Last verified: August 2011

December 3, 2009
March 27, 2013
April 2009
October 2009   (final data collection date for primary outcome measure)
  • Pharmacokinetics of safinamide after single dose administration (Cmax) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of safinamide after single dose administration (AUC) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Pharmacokinetics of safinamide after single dose administration [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01027169 on ClinicalTrials.gov Archive Site
  • Safety and tolerability after single dose administration of safinamide (Adverse Events) [ Time Frame: 12 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of safinamide metabolite NW1153 (Cmax) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of safinamide metabolite NW1153 (AUC) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of safinamide metabolite NW1689 (Cmax) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics of safinamide metabolite NW1689 (AUC) [ Time Frame: 10 days ] [ Designated as safety issue: No ]
Safety and tolerability after single dose administration of safinamide [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Hepatic Impairment
Drug: safinamide
single dose of 50mg safinamide on Day 1
  • Experimental: Arm 1
    subjects with mild hepatic impairment
    Intervention: Drug: safinamide
  • Experimental: Arm 2
    subjects with moderate hepatic impairment
    Intervention: Drug: safinamide
  • Experimental: Arm 3
    matched subjects with normal hepatic function
    Intervention: Drug: safinamide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
Not Provided
October 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01027169
28696
Not Provided
Newron Sweden AB
Newron Sweden AB
Not Provided
Principal Investigator: Atef Halabi, MD CRS Clinical Research Services Kiel GmbH
Newron Sweden AB
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP