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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 19 March 2012
Main ID:  EUCTR2004-002390-23-DE
Date of registration: 30/11/2004
Prospective Registration: No
Primary sponsor: Aventis Pharma Ltd.
Public title: Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects
Scientific title: Evaluation of the pharmacokinetic profile of Riluzole (XRP4274) and RPR112512 following multiple oral administrations of XRP4274 for 8 days in healthy Japanese and Caucasian male subjects
Date of first enrolment: 24/11/2004
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002390-23
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: Double blind: Parallel group: yes Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no  
Phase: 
Countries of recruitment
Germany
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
Healthy male subjects aged between 20 and 45 years, inclusive.
Ethnic origin
- White residing in Europe and/or North America
- Japanese with a Japanese citizenship and both parents of Japanese ethnic origin.
Japanese subjects must have been residing in Europe and/or North America for less than 10 years at the time of giving written consent.
Body Mass Index between 18.5 and 27 kg/m2, inclusive, with a weight range of 50 kg – 90 kg.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
As a result of any of the screening assessments the responsible physician considers the subject unfit for the inclusion.
Subjects currently smoke or have smoked during the last 6 months or they have a smoking history of more than 5 packs year (1pack year is the equivalent of 20 cigarettes per day per year).
Consumption of a large quantity of coffee, tea (= 6 cups/days) or equivalent.
Consumption of a large amounts of cruciferous vegetables (Brussel sprouts, cabbage, broccoli, turnip, cauliflower), i.e. more than two times per week
Consumption of a large amounts of charcoal-broiled food, i.e. more than two times per week
Contraindications from
? the medical history and physical examination
? laboratory tests (hematology/coagulation, clinical chemistry, and urinalysis by dipstick)
? 12-lead electrocardiogram
? blood pressure and pulse (only pulse to be measurable in that form)
? hepatitis and HIV screen
Symptoms of a clinically significant illness in the 3 months before the study
Presence or sequelae of gastrointestinal, liver or kidney disease, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs
History of drug or alcohol abuse
Subjects who are taking regular (or a course of) medication whether prescribed or not.



Age minimum:
Age maximum:
Gender:
Female:
Male: yes
Health Condition(s) or Problem(s) studied
amyotrophic lateral sclerosis
Classification code 10002026
Intervention(s)

Trade Name: RILUTEK
Product Name: RILUTEK 50 mg, film-coated tablets
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: riluzole
Current Sponsor code: XRP4274
Concentration unit: mg milligram(s)
Concentration number: 50-

Primary Outcome(s)
Secondary Objective: To assess the safety and tolerance after multiple oral administration of XRP4274 in healthy Japanese and Caucasian male subjects
Main Objective: To evaluate and compare the plasma pharmacokinetics of Riluzole and RPR112512 after multiple oral administration of XRP4274 in healthy Japanese and Caucasian male subjects
Primary end point(s): Cmax (ng/mL), AUC (hr·ng/mL), CL (mL/min), Tmax (hr), T1/2 (hr) of Riluzole and RPR112512 in plasma
Secondary Outcome(s)
Secondary ID(s)
XRP4274E/4101
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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