The effects of intravenous heme arginate on functional magnetic resonance imaging during ischemia - HEME in MRI

Conditions: ischemia reperfusion injury
MedDRA version: 9.1Level: LLTClassification code 10034578Term: Peripheral ischemia

Registration Number: EUCTR2008-006967-35-AT

Lead Sponsor: Medizinische Universität Wien, Universitätsklinik für klinische Pharmakologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: Not specified

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

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