Status:
COMPLETED
Effects of Heme Arginate in Healthy Male Subjects
Lead Sponsor:
Daniel Doberer
Conditions:
Healthy Subjects
Heme Oxygenase
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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 promot...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00682370
Start Date
October 1 2007
End Date
July 1 2008
Last Update
January 15 2013
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090