E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Effects on sleep electroencephalogram and motoric learning in healthy volunteers related to the permeability of the blood-brain-barrier related to genotypes of the ABCB 1 gene |
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MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test whether in healthy volunteers with the genotype A/A of the ABCB1 gene the brain concentration of escitaloprame as assessed by 19-fluor-magnetic-resonance spectroscopy is significantly lower than in subjects with the genotype B/B |
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E.2.2 | Secondary objectives of the trial |
To test- whether sleep electroencephalogram (EEG) variables differ after 6 days treatment with escitaloprame significantly versus baseline (before treatment), -whether sleep-EEG variables of healthy volunteers with genotypes A/A versus B/B of the ABCB1 gene differ after 6 days treament with escitaloprame, -whether motoric learning assessed by the finger tapping task differs in the subjects after 6 days treatment with escitaloprame compared to baseline, -whether motoric learning differs between subjects with genotypes A/A and B/B after 6 days treatment with escitaloprame, -whether the concentrations of escitaloprame in the brain, assessed by 19-fluor-magnetic-resonance spectroscopy correlate with the serum concentrations of the substance, -whether there are significant differences of these effects in subjects 20 to 30 years, and 50 to 60 years old, respectively. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
healthy male volunteers, 20 to 30, or 50 to 60 years old, genotype A/A or B/B of the ABCB1 gene, capable to perform all tests and examinations, capable to understand the aims of the study, written informed consent. |
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E.4 | Principal exclusion criteria |
participation in another trial during the last month, psychiatric disorders, present or during life time, sleep disorders present or during the last 3 months, night work or transmeridian flight during the last 3 months, serious somatic disorders, intake of drugs during more than 2 days during the last 3 months, any drug intake during the last month, smoker, abuse of alcohol, more than 2 cups coffee per day, recreational drugs during the last 4 months.
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E.5 End points |
E.5.1 | Primary end point(s) |
escitaloprame brain and serum concentrations, sleep EEG motoric learning
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
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 | Yes |
E.8.2.3.1 | Comparator description |
baseline, without treatment |
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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 | Yes |
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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development of an exclusion criterion,e.g. a disease, decision of of the investigator, e.g. changes of laboratory variables, decision of the volunteer, noncompliance of the volunteer |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 6 |