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

• Conditions: amyotrophic lateral sclerosis; Classification code 10002026

• Registration Number: EUCTR2004-002390-23-DE
• Lead Sponsor: Aventis Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified