Safinamide Renal Impairment Trial

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: 50mg safinamide

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Schleswig-Holstein
    • Kiel, Schleswig-Holstein, Germany
      • CRS Clinical Research Services Kiel GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Subjects with moderate renal impairment	Drug: 50mg safinamide; 50 mg safinamide on Day 1
Experimental: Group 2; Subjects with severe renal impairment	Drug: 50mg safinamide; 50 mg safinamide on Day 1
Experimental: Group 3; Matched subjects with normal renal function	Drug: 50mg safinamide; 50 mg safinamide on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide	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	12 to 14 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Newron Pharmaceuticals SPA
• Investigators: Study Director: Anne Marquet, PharmaD, PhD, Merck Serono S.A., Geneva

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: June 14, 2011
• First Submitted That Met QC Criteria: June 14, 2011
• First Posted (Estimate): June 15, 2011

Study Record Updates

• Last Update Posted (Estimate): March 29, 2013
• Last Update Submitted That Met QC Criteria: March 28, 2013
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: pharmacokinetics; renal impairment; safinamide; Moderate and Severe Renal Impairment
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: EMR701165_025