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Safinamide Renal Impairment Trial

NCT ID: NCT01374113

Last Updated: 2013-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Brief Summary

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The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal function.

Detailed Description

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Conditions

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Renal Impairment

Keywords

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safinamide pharmacokinetics renal impairment Moderate and Severe Renal Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Subjects with moderate renal impairment

Group Type EXPERIMENTAL

50mg safinamide

Intervention Type DRUG

50 mg safinamide on Day 1

Group 2

Subjects with severe renal impairment

Group Type EXPERIMENTAL

50mg safinamide

Intervention Type DRUG

50 mg safinamide on Day 1

Group 3

Matched subjects with normal renal function

Group Type EXPERIMENTAL

50mg safinamide

Intervention Type DRUG

50 mg safinamide on Day 1

Interventions

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50mg safinamide

50 mg safinamide on Day 1

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Renally impaired subjects - Subject with different degrees of renal impairment: moderate and severe renal impairment as assessed by Estimated Glomerular Filtration Rate (eGFR) according to Modification of Diet in Renal Disease (MDRD) equation at screening
2. Healthy subjects - Subject is in good age-appropriate physical and mental health as established by medical history, physical examination, electrocardiogram (ECG) and vital signs recordings, and results of biochemistry, haematology, coagulation and urinalysis testing within 3 weeks prior to dosing
3. All subjects have given written informed consent before any study-related activities are carried out

Exclusion Criteria

1. Any other clinically relevant disease, condition, or therapy, which in the Investigator's opinion would exclude the subject from the trial, may pose a risk to the subject or interfere with the trial objectives.
2. Existence of surgical or medical condition, which, in the judgment of the Investigator, might interfere with the absorption, metabolism, or excretion of the drug and/or gastrointestinal motility
3. Renally impaired subjects - Acute renal failure of any etiology (including viral, toxic, or drug induced), renal transplantation within the previous 12 months, uncontrolled diabetes mellitus as judged by the Investigator, use of any drug affecting gastric acid secretion, such as proton pump inhibitors and antacids received within 48 hours prior to drug administration and for 24 hours after administration, Chronic heart failure (CHF) New York Heart Association (NYHA) class III and IV despite treatment at screening, change in used medication (prescribed by a physician or over-the-counter \[OTC\] medication) within 14 days prior to safinamide administration. Concomitant medication used for the treatment of renal impairment and accompanying diseases may be continued during the trial.
4. Healthy subjects - Use of any medication, including multi-vitamin preparations, received within 21 days prior to 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 trial drug administration.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Newron Pharmaceuticals SPA

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Marquet, PharmaD, PhD

Role: STUDY_DIRECTOR

Merck Serono S.A., Geneva

Locations

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CRS Clinical Research Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

Other Identifiers

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EMR701165_025

Identifier Type: -

Identifier Source: org_study_id