Overview

Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Status:
Terminated
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Radboud University
Collaborator:
Dutch Diabetes Research Foundation
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