Heme Oxygenase (HO) Activity and Adenosine Induced Vasodilation

R

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

6 participants in 2 patient groups

1
Experimental group
Description:
L-arginine treatment first, heme arginate treatment second
Treatment:
Drug: L-arginine + heme arginate
2
Experimental group
Description:
Heme arginate treatment first, L-arginine treatment second
Treatment:
Drug: Heme arginate + L-arginine

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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