NCT01374113

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

June 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 15, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Last Updated

March 29, 2013

Status Verified

October 1, 2011

Enrollment Period

4 months

First QC Date

June 14, 2011

Last Update Submit

March 28, 2013

Conditions

Renal Impairment

Keywords

safinamidepharmacokineticsrenal impairmentModerate and Severe Renal Impairment

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (3)

Group 1

EXPERIMENTAL

Subjects with moderate renal impairment

Drug: 50mg safinamide

Group 2

EXPERIMENTAL

Subjects with severe renal impairment

Drug: 50mg safinamide

Group 3

EXPERIMENTAL

Matched subjects with normal renal function

Drug: 50mg safinamide

Interventions

50mg safinamideDRUG

50 mg safinamide on Day 1

Group 1Group 2Group 3

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • All subjects have given written informed consent before any study-related activities are carried out

You may not qualify if:

  • 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.
  • 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
  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CRS Clinical Research Services Kiel GmbH

Kiel, Schleswig-Holstein, Germany

Location

MeSH Terms

Conditions

Renal InsufficiencyLymphoma, Follicular

Interventions

safinamide

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Anne Marquet, PharmaD, PhD

    Merck Serono S.A., Geneva

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2011

First Posted

June 15, 2011

Study Start

June 1, 2011

Primary Completion

October 1, 2011

Last Updated

March 29, 2013

Record last verified: 2011-10

Locations

DE(1)