TerminatedInterventionalPhase 4Updated Aug 11, 2011
Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation
ClinicalTrials.gov ID
NCT00856817
Lead Sponsor
Radboud University Medical CenterOTHER
Overall Status
Terminated
Study Type
Interventional
Phase
Phase 4
Enrollment
6Estimated
Last Update Posted
Aug 11, 2011Estimated
Start Date
Mar 2009
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.
Atherosclerotic Cardiovascular Disease
L-arginine + heme arginate
Heme arginate + L-arginine
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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