E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ischemia reperfusion injury |
|
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 | 10023034 |
E.1.2 | Term | Ischemia peripheral |
|
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 assess whether mechanical post-conditioning prevents skeletal muscle IR injury. To study whether high concentrations of exogenous vitamin C prevent skeletal muscle IR injury.
|
|
E.2.2 | Secondary objectives of the trial |
To provide data about the time course of high energy phosphate levels (ATP, phosphocreatine and inorganci phosphate) and pH in skeletal muscle tissue after the onset of ischemia and reperfusion. To determine systemic plasma concentrations of vitamin C and of markers of oxidative stress before and after 20 minutes of leg ischemia in the absence and presence of post-conditioning or vitamin C administration To determine the concentration of cellular proteins like NF-κB before and after the onset of ischemia
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Men aged between 18 and 45 years - Nonsmoker for more than 3 months - Body mass index between 18 and 25 kg/m2 - Normal findings in medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant
|
|
E.4 | Principal exclusion criteria |
Any of the following will exclude a subject from the study: - Regular use of medication, abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preciding the study - Evidence of hypertension, pathologic hyperglycemia, hyperlipidemia - Treatment in the previous 3 weeks with any drug including over-the-counter drugs. - Symptoms of a clinically relevant illness in the 2 weeks before the first study day - History or presence of gastrointestinal, liver of kidney disease, or other conditions known to interfere with distribution, metabolism or excretion of the study drug - Blood donation during the previous 3 weeks - History of hypersensitivity to parenteral vitamin C. - Glucose-6-phosphate dehydrogenase deficiency - Thalassemia, haemochromatosis - History of urolithiasis - Any magnetic or paramagnetic device not removable - Claustrophobia - Regular use of supplementary oral Vitamin C or Vitamin C containing substances
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Change in cellular high energy phosphate levels and venous pH concentration
|
|
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 | 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) | 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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
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 | No |
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 | 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 | 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
|
End of trial will be the last visit of the last subject. Estimated maximum duration is one year. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |