Heme Arginate in Functional Magnetic Resonance Imaging (fMRI)

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Male

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) magnetic resonance imaging (MRI) shall evaluate the effects of HO-1 induction during short-time ischemia in skeletal muscle of healthy subjects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: MWolzt

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

Exclusion Criteria:

• 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