Safinamide Renal Impairment Trial

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newron Sweden AB
ClinicalTrials.gov Identifier:
NCT01374113
First received: June 14, 2011
Last updated: March 28, 2013
Last verified: October 2011
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Drug: 50mg 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 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

Further study details as provided by Newron Sweden AB:

Primary Outcome 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax of safinamide metabolite NW-1689 in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]
  • Cmax of safinamide metabolite NW-1153 in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]
  • Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]
  • AUC0-∞ of safinamide metabolite NW-1689 in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]
  • AUC0-∞ of safinamide metabolite NW-1153 in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]
  • AUC0-∞ of safinamide metabolite NW-1689 acylglucuronide in plasma [ Time Frame: 12 to 14 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374113

Locations
Germany
CRS Clinical Research Services Kiel GmbH
Kiel, Schleswig-Holstein, Germany
Sponsors and Collaborators
Newron Sweden AB
Investigators
Study Director: Anne Marquet, PharmaD, PhD Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: Newron Sweden AB
ClinicalTrials.gov Identifier: NCT01374113     History of Changes
Other Study ID Numbers: EMR701165_025
Study First Received: June 14, 2011
Last Updated: March 28, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Newron Sweden AB:
safinamide
pharmacokinetics
renal impairment
Moderate and Severe Renal Impairment

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014