NCT00682370

Effects of Heme Arginate in Healthy Male Subjects

Dose Escalation, Randomized, Placebo Controlled Study to Investigate the Effects of Intravenous Heme Arginate on Heme Oxygenase-1 (HO-1) and Heme Metabolism in Association With HO-1 Gene GTn Promoter Polymorphism in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Daniel Doberer · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

Heme oxygenase 1 (HO-1) serves as a protective gene. It has been shown that one factor modulating HO-1 activity is a genetic variation in the HO-1 gene (functional GT length polymorphism in the promotor region). Heme arginate is a strong inducer of HO-1 as shown in several animal experimental studies. The aim of this clinical trial is to evaluate the HO-1 stimulation of heme arginate in healthy humans.

Conditions

• Healthy Subjects
• Heme Oxygenase
• Genetic Polymorphism

Interventions

Type	Name	Description
DRUG	saline solution	intravenous infusion, single dose
DRUG	heme arginate	intravenous infusion, single dose 0.3 mg/kg heme arginate
DRUG	heme arginate	intravenous infusion, single dose 1 mg/kg heme arginate
DRUG	heme arginate	intravenous infusion, single dose 3 mg/kg heme arginate

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2008-05-22
• Last updated: 2013-01-15

Locations

1 site across 1 country: Austria