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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier:
NCT01027169
First received: December 3, 2009
Last updated: March 27, 2013
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatic Impairment
 Drug: safinamide
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Newron Pharmaceuticals S.p.A.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: April 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
subjects with mild hepatic impairment
 Drug: safinamide
single dose of 50mg safinamide on Day 1
Experimental: Arm 2
subjects with moderate hepatic impairment
 Drug: safinamide
single dose of 50mg safinamide on Day 1
Experimental: Arm 3
matched subjects with normal hepatic function
 Drug: safinamide
single dose of 50mg safinamide on Day 1

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01027169

Locations
Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
Sponsors and Collaborators
Newron Pharmaceuticals S.p.A.
Investigators
Principal Investigator: Atef Halabi, MD CRS Clinical Research Services Kiel GmbH
  More Information

No publications provided

Responsible Party: Newron Pharmaceuticals S.p.A.
ClinicalTrials.gov Identifier: NCT01027169     History of Changes
Other Study ID Numbers: 28696
Study First Received: December 3, 2009
Last Updated: March 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Newron Pharmaceuticals S.p.A.:
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

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013