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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014