amyotrophic lateral sclerosis Classification code 10002026
Conditions
Interventions
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 milligra
Sponsors
Aventis Pharma Ltd.
Eligibility
Sex/Gender
Male
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;Secondary Objective: To assess the safety and tolerance 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 | — |
Countries
Germany
Outcome results
None listed