Status:
UNKNOWN
Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)
Lead Sponsor:
MWolzt
Conditions:
Ischemia-reperfusion Injury
Eligibility:
MALE
18-46 years
Phase:
PHASE2
Brief Summary
Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. Functional blood oxygen level dependent (BOLD) mag...
Detailed Description
Ischemia reperfusion injury may be attenuated by HO-1 induction. Heme arginate showed protective effects during prolonged ischemia in animal studies. The investigators previous data confirmed strong H...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 weeks 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01461512
Start Date
January 1 2009
End Date
December 1 2011
Last Update
October 28 2011
Active Locations (1)
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1
Medical University of Vienna, Department of Clinical Pharmacology
Vienna, Austria, 1090