NCT01027169

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 7, 2009

Completed
Last Updated

March 29, 2013

Status Verified

August 1, 2011

Enrollment Period

6 months

First QC Date

December 3, 2009

Last Update Submit

March 27, 2013

Conditions

Hepatic Impairment

Keywords

Hepatic impairmentLiver diseasesPharmacokineticsTo Investigate Pharmacokinetics of Safinamide in Subjects With Mild and Moderate Hepatic Impairment as Compared to Healthy Subjects With Normal Hepatic Function

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetics of safinamide after single dose administration (Cmax)

    10 days

  • Pharmacokinetics of safinamide after single dose administration (AUC)

    10 days

Secondary Outcomes (5)

  • Safety and tolerability after single dose administration of safinamide (Adverse Events)

    12 days

  • Pharmacokinetics of safinamide metabolite NW1153 (Cmax)

    10 days

  • Pharmacokinetics of safinamide metabolite NW1153 (AUC)

    10 days

  • Pharmacokinetics of safinamide metabolite NW1689 (Cmax)

    10 days

  • Pharmacokinetics of safinamide metabolite NW1689 (AUC)

    10 days

Study Arms (3)

Arm 1

EXPERIMENTAL

subjects with mild hepatic impairment

Drug: safinamide

Arm 2

EXPERIMENTAL

subjects with moderate hepatic impairment

Drug: safinamide

Arm 3

EXPERIMENTAL

matched subjects with normal hepatic function

Drug: safinamide

Interventions

safinamideDRUG

single dose of 50mg safinamide on Day 1

Arm 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Germany

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

safinamide

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

  • Atef Halabi, MD

    CRS Clinical Research Services Kiel GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2009

First Posted

December 7, 2009

Study Start

April 1, 2009

Primary Completion

October 1, 2009

Last Updated

March 29, 2013

Record last verified: 2011-08

Locations

DE(1)