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Effects of Heme Arginate in Healthy Male Subjects

NCT00682370 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2013-01-15

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Daniel Doberer

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00682370 on ClinicalTrials.gov