E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ischemia reperfusion injury |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10034578 |
E.1.2 | Term | Peripheral ischemia |
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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 |
1) To evaluate the effects of HO – 1 induction on the time course of high-energy phosphate levels (ATP, phosphocreatine and inorganic phosphate) and pH as well as oxygenation levels in ischemic skeletal muscle tissue continuously starting before the onset of ischemia ending about 15 minutes after reperfusion.
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E.2.2 | Secondary objectives of the trial |
2) To evaluate the short and long time effects of HO – 1 induction on cell surface markers of activation after ischemic injury measured by flow cytometry
3) To assess whether HO – 1 induction prevents or alleviates skeletal muscle IR injury.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Signed informed consent - Men aged between 18 and 46 years (inclusive) - Nonsmoker for more than 3 months - Body mass index between 18 and 27 kg/m2 - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant - Negative results from urine drug screen if performed - Ability to communicate well with the investigator in the local language and to understand and comply with the requirements of the study
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E.4 | Principal exclusion criteria |
Any of the following will exclude a subject from the study: - Known hypersensitivity to the study drug or any excipients of the drug formulation - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study - Treatment with another investigational drug within 3 months prior to screening - History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drug - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug including over-the-counter drugs (including herbal medicines such as St John’s Wort) - Symptoms of a clinically relevant illness in the 2 weeks before the first study day - Blood donation during the previous 3 weeks - Any metallic, electric, electronic or magnetic device or object not removable - Claustrophobia
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E.5 End points |
E.5.1 | Primary end point(s) |
MRI target variables will be summarized to obtain the arithmetic mean, standard deviation, median, coefficient of variation (%), minimum, and maximum. Effects of HO-1 induction on high-energy phosphates or tissue oxygen saturation will be expressed as % change from baseline (Δ%) (p < 0.05 will be considered the level of significance). All effects will be assessed by repeated measurements ANOVA.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
E.8.1.6 | Cross over | Yes |
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.8.3 |
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 | No |
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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The end of the trial is the last visit of the last subject |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |