Normosang treatment will be used to evaluate heme oxygenase induction in healthy subjects. Results will be used for future studies concerning diabetes related cardiovascular disease. MedDRA version: 9.1 Level: LLT Classification code 10051615 Term: Atherosclerotic cardiovascular disease
Conditions
Sponsors
RUNMC
Eligibility
Sex/Gender
All
Inclusion 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 testing should be within the laboratory’s reference ranges. Determinants of renal and hepatic function should be within twice the upper limit of normal range. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 •Heterozygosity (“LS”) or homozygosity (“LL”) with regard to the number of GT repeats in the HO-1 promoter region
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the effect of heme arginate (Normosang) on forearm vasodilator response and HO-1 activity in easily inducible subjects, as reflected by levels of carboxyhemoglobin, bilirubin, haem, ferritin and end tidal CO. ;Secondary Objective: To determine the effect of heme arginate (Normosang) on HO-1 mRNA level, HO-1 protein level and HO-1 activity level in peripheral blood mononuclear cells of easily inducible subjects. To determine the effect of heme arginate (Normosang) on the expression of the A2A receptor assessed by the mRNA level in peripheral blood mononuclear cells of easily inducible subjects. ;Primary end point(s): •HO mRNA level in PBMCs •Forearm vasodilator response to adenosine assessed by silastic strain gauge plethysmography | — |
Countries
Netherlands
Outcome results
None listed