Status:
TERMINATED
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
Lead Sponsor:
Radboud University Medical Center
Collaborating Sponsors:
Dutch Diabetes Research Foundation
Conditions:
Atherosclerotic Cardiovascular Disease
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine whether heme oxygenase 1 induction by heme arginate treatment is of influence on adenosine induced vasodilation in healthy individuals.
Eligibility Criteria
Inclusion
- at least 18 and no older than 65 on the day of first dosing
- healthy
- Quetelet Index (Body Mass Index) of 18 to 30 kg/m2
- In general, results of haematology and chemistry should be within the laboratory's reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range.
Exclusion
- Documented history of sensitivity / idiosyncrasy to medicinal products or excipients
- history of smoking within the past year
- history of or current abuse of drugs, alcohol and/or solvents
- Current use of any (over the counter) medication potentially influencing heme oxygenase or the cardiovascular system
- Inability to understand the nature and extent of the trial and the procedures required
- Participation to a drug trial within 60 days prior to the first dose
- Febrile illness within 3 days before the first dose
- Heterozygosity (LS) or homozygosity (LL) with regard to the number of GT repeats in the HO-1 promoter region
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00856817
Start Date
March 1 2009
Last Update
August 11 2011
Active Locations (1)
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1
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands