Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

Radboud University Medical Center

Status and phase

Terminated

Phase 4

Conditions

Atherosclerotic Cardiovascular Disease

Treatments

Drug: Heme arginate + L-arginine

Drug: L-arginine + heme arginate

Study type

Interventional

Funder types

Other

Identifiers

NCT00856817

HOADO

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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