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Sponsored by: |
Medical University of Vienna |
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Information provided by: | Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT00682370 |
Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.
Condition | Intervention | Phase |
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Healthy Subjects Heme Oxygenase Genetic Polymorphism |
Drug: saline solution Drug: heme arginate |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | Dose Escalation, Randomized, Placebo Controlled Study to Investigate the Effects of Intravenous Heme Arginate on Heme Oxygenase-1 (HO-1) and Heme Metabolism in Association With HO-1 Gene GTn Promoter Polymorphism in Healthy Male Subjects |
Enrollment: | 15 |
Study Start Date: | October 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A1: Experimental
0.3 mg/kg heme arginate
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Drug: heme arginate
intravenous infusion, single dose 0.3 mg/kg heme arginate |
A2: Experimental
1 mg/kg heme arginate
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Drug: heme arginate
intravenous infusion, single dose 1 mg/kg heme arginate |
A3: Experimental
3 mg/kg heme arginate
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Drug: heme arginate
intravenous infusion, single dose 3 mg/kg heme arginate |
P: Placebo Comparator
Placebo
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Drug: saline solution
intravenous infusion, single dose
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Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Department of Clinical Pharmacology ( Michael Wolzt ) |
Study ID Numbers: | EudraCT - 2007-003790-11 |
Study First Received: | May 16, 2008 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00682370 |
Health Authority: | Austria: Agency for Health and Food Safety |
Nitroglycerin Healthy |