ischemia reperfusion injury MedDRA version: 9.1 Level: LLT Classification code 10034578 Term: Peripheral ischemia
Conditions
Interventions
Trade Name: Normosang
Product Name: Normosang
Product Code: PL 15266/008
Pharmaceutical Form: Intravenous infusion
Pharmaceutical form of the placebo: Intravenous infusion
Route of administration of
Sponsors
Medizinische Universität Wien, Universitätsklinik für klinische Pharmakologie
Eligibility
Sex/Gender
Male
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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. ;Secondary Objective: 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. ;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 (?%) (p < 0.05 will be considered the level of significance). All effects will be assessed by repeated measurements ANOVA. | — |
Countries
Austria
Outcome results
None listed