Effects of Heme Arginate in Healthy Male Subjects
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy Subjects; Heme Oxygenase; Genetic Polymorphism
Intervention: saline solution (Drug); heme arginate (Drug); heme arginate (Drug); heme arginate (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Medical University of Vienna Overall contact:
Michael Wolzt, MD, Phone: 43-14-0400, Ext: 2981, Email: michael.wolzt@meduniwien.ac.at
Summary
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.
Clinical Details
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
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Primary outcome: The maximal HO-1 mRNA expression in PBMCs
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Male.
Criteria:
Inclusion Criteria:
- Signed informed consent prior to any study-mandated procedure.
- Male aged between 18 and 45 years (inclusive) at screening.
- No clinically significant findings on the physical examination at screening.
- Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
- 12-lead ECG without clinically relevant abnormalities at screening.
- Hematology, clinical chemistry, and urinalysis test results not deviating from the
normal range to a clinically relevant extent at screening.
- Negative results from urine drug screen at screening.
- 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.
- Treatment with another investigational drug within 3 months prior to screening.
- History or clinical evidence of alcoholism or drug abuse within the 3-year period
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 drugs.
- Smoking within the last 3 months prior to screening.
- Previous treatment with any prescribed or OTC medications (including herbal medicines
such as St John's Wort) within 2 weeks prior to screening.
- Loss of 250 ml or more of blood within 3 months prior to screening.
- Positive results from the hepatitis serology, except for vaccinated subjects, at
screening.
- Positive results from the HIV serology at screening.
- Presumed non-compliance.
- Legal incapacity or limited legal capacity at screening.
Locations and Contacts
Michael Wolzt, MD, Phone: 43-14-0400, Ext: 2981, Email: michael.wolzt@meduniwien.ac.at
Medical University of Vienna, Vienna 1090, Austria; Recruiting
Additional Information
Department of Clinical Pharmacology, Medical University of Vienna
Starting date: October 2007
Ending date: October 2008
Last updated: May 21, 2008
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