Effects of Heme Arginate in Healthy Male Subjects (HEMAHS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daniel Doberer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT00682370
First received: May 16, 2008
Last updated: January 13, 2013
Last verified: January 2013
  Purpose

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 Intervention Phase
Healthy Subjects
Heme Oxygenase
Genetic Polymorphism
Drug: saline solution
Drug: heme arginate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (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

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • The maximal HO-1 mRNA expression in PBMCs [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: saline solution
intravenous infusion, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682370

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

Additional Information:
No publications provided

Responsible Party: Daniel Doberer, Studienleiter, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT00682370     History of Changes
Other Study ID Numbers: EudraCT - 2007-003790-11
Study First Received: May 16, 2008
Last Updated: January 13, 2013
Health Authority: Austria: Agency for Health and Food Safety

ClinicalTrials.gov processed this record on April 17, 2014