E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
amyotrophic lateral sclerosis |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Classification code | 10002026 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate and compare the plasma pharmacokinetics of Riluzole and RPR112512 after multiple oral administration of XRP4274 in healthy Japanese and Caucasian male subjects |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerance after multiple oral administration of XRP4274 in healthy Japanese and Caucasian male subjects |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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last visit of the last subject enrolled |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |