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Effects of Heme Arginate in Healthy Male Subjects (HEMAHS)

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ClinicalTrials.gov Identifier: NCT00682370
Recruitment Status : Completed
First Posted : May 22, 2008
Last Update Posted : January 15, 2013
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Heme Oxygenase Genetic Polymorphism Drug: saline solution Drug: heme arginate Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2007
Primary Completion Date : July 2008
Study Completion Date : July 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: A1
0.3 mg/kg heme arginate
Drug: heme arginate

intravenous infusion, single dose

0.3 mg/kg heme arginate

Experimental: A2
1 mg/kg heme arginate
Drug: heme arginate

intravenous infusion, single dose

1 mg/kg heme arginate

Experimental: A3
3 mg/kg heme arginate
Drug: heme arginate

intravenous infusion, single dose

3 mg/kg heme arginate

Placebo Comparator: P
Drug: saline solution
intravenous infusion, single dose

Outcome Measures

Primary Outcome Measures :
  1. The maximal HO-1 mRNA expression in PBMCs [ Time Frame: 2 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Signed informed consent prior to any study-mandated procedure.
  • Male aged between 18 and 45 years (inclusive) at screening.
  • No clinically significant findings on the physical examination at screening.
  • Body mass index (BMI) between 18 and 28 kg/m2 (inclusive) at screening.
  • 12-lead ECG without clinically relevant abnormalities at screening.
  • Hematology, clinical chemistry, and urinalysis test results not deviating from the normal range to a clinically relevant extent at screening.
  • Negative results from urine drug screen at screening.
  • Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study.

Exclusion Criteria:

  • Known hypersensitivity to the study drug or any excipients of the drug formulation.
  • Treatment with another investigational drug within 3 months prior to screening.
  • History or clinical evidence of alcoholism or drug abuse within the 3-year period prior to screening.
  • History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study drugs.
  • Smoking within the last 3 months prior to screening.
  • Previous treatment with any prescribed or OTC medications (including herbal medicines such as St John's Wort) within 2 weeks prior to screening.
  • Loss of 250 ml or more of blood within 3 months prior to screening.
  • Positive results from the hepatitis serology, except for vaccinated subjects, at screening.
  • Positive results from the HIV serology at screening.
  • Presumed non-compliance.
  • Legal incapacity or limited legal capacity at screening.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00682370

Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Daniel Doberer
More Information

Additional Information:
Responsible Party: Daniel Doberer, Studienleiter, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00682370     History of Changes
Other Study ID Numbers: EudraCT - 2007-003790-11
First Posted: May 22, 2008    Key Record Dates
Last Update Posted: January 15, 2013
Last Verified: January 2013