E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Physiological processes [G07] |
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 analyze the effect of xenon-inhalation on erythropoetin-level in blood of healthy volunteers and to determine the efficient time of inhalation.
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E.2.2 | Secondary objectives of the trial |
First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1α, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them)
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male subjects, age >18 years, legally competent to sign, without any known medical condition or medication prescribed at the Uniklinik RWTH Aachen Persons that are able and willing to understand and follow the instructions of the study personnel. Signed informed consent.
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E.4 | Principal exclusion criteria |
Smoker, alcoholic or person who regularly consumes drugs or medication. Persons with a medical condition that is contraindicated with the planned treatment. Known hypersensivity against xenon. Persons not legally competent to sign. Simultaneous participation at any other trial. Blood-loss due to trauma during the period of the study or 2 months previous. Blood donation during the period of the study or 2 months previous.
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of erythropoetin-levels in blood of healthy volunteers directly after xenon-application and during > 120 h.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
during > 120 h after xenon-application |
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E.5.2 | Secondary end point(s) |
First-order elimination of xenon after xenon-inhalation in blood and exhalation air by mass-spektroskopy. Determination of hemodynamic parameters (HF, RR, EKG, SpO2, rSO2, tSO2) Laboratory parameters: Inflammation (procalcitonin, IL-6, IL-10, leukocytes, thrombocytes), growht factors (Hypoxia inducible factor (HIF)1α, Fibroblast Growth Factors (FGFs), Hepatocyte Growth Factor (HGF), Mechano Growth Factors (MGFs), Platelet-Derived Growth Factor (PDGF), Vascular-Endothelial Growth Factor (VEGF), IL-8, VEGF, MIF and SDF-1a) Oxidative stress: total oxidative capacity (TOC), peroxide activity (EPA assay), LDL antibodies: antibody against oxided LDL, e.g. MDA-LDL IgM or oLAb (IgG) or even both of them)
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Before each inhalation Directely after the first inhalation 2 h after the first inhalation 4 h after the first inhalation 8 h after the first inhalation 22-24 h after each inhalation 46-48 h after each inhalation 70-72 h after the last inhalation 94-96 h after the last inhalation 118-120 h after the last inhalation
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
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 | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 24 |
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 | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |