Safinamide Renal Impairment Trial

Overview

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.

Full Title of Study: “An Open-label, Parallel-group, Single Center, Single Oral Dose Trial to Investigate the Pharmacokinetics (PK) of 50 mg Safinamide in Subjects With Moderate and Severe Renal Impairment Compared to Matched Subjects With Normal Renal Function”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2011

Interventions

  • Drug: 50mg safinamide
    • 50 mg safinamide on Day 1

Arms, Groups and Cohorts

  • Experimental: Group 1
    • Subjects with moderate renal impairment
  • Experimental: Group 2
    • Subjects with severe renal impairment
  • Experimental: Group 3
    • Matched subjects with normal renal function

Clinical Trial Outcome Measures

Primary Measures

  • Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
    • Time Frame: 12 to 14 days
  • AUC0-∞ of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide
    • Time Frame: 12 to 14 days

Secondary Measures

  • Cmax of safinamide metabolite NW-1689 in plasma
    • Time Frame: 12 to 14 days
  • Cmax of safinamide metabolite NW-1153 in plasma
    • Time Frame: 12 to 14 days
  • Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma
    • Time Frame: 12 to 14 days
  • AUC0-∞ of safinamide metabolite NW-1689 in plasma
    • Time Frame: 12 to 14 days
  • AUC0-∞ of safinamide metabolite NW-1153 in plasma
    • Time Frame: 12 to 14 days
  • AUC0-∞ of safinamide metabolite NW-1689 acylglucuronide in plasma
    • Time Frame: 12 to 14 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Newron Pharmaceuticals SPA
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anne Marquet, PharmaD, PhD, Study Director, Merck Serono S.A., Geneva

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