Safinamide Renal Impairment Trial

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01374113
• Other study ID #: EMR701165_025
• Status: Completed
• Phase: Phase 1
• First received: June 14, 2011
• Last updated: March 28, 2013
• Start date: June 2011

Study information

• Verified date: October 2011
• Source: Newron
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
Germany	CRS Clinical Research Services Kiel GmbH	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
Newron

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	AUC0-8 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	No
Secondary	Cmax of safinamide metabolite NW-1689 in plasma		12 to 14 days	No
Secondary	Cmax of safinamide metabolite NW-1153 in plasma		12 to 14 days	No
Secondary	Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma		12 to 14 days	No
Secondary	AUC0-8 of safinamide metabolite NW-1689 in plasma		12 to 14 days	No
Secondary	AUC0-8 of safinamide metabolite NW-1153 in plasma		12 to 14 days	No
Secondary	AUC0-8 of safinamide metabolite NW-1689 acylglucuronide in plasma		12 to 14 days	No