Effects of Heme Arginate in Healthy Male Subjects

Healthy Subjects Clinical Trial

— HEMAHS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00682370
• Other study ID #: EudraCT - 2007-003790-11
• Status: Completed
• Phase: Phase 1
• First received: May 16, 2008
• Last updated: January 13, 2013
• Start date: October 2007
• Est. completion date: July 2008

Study information

• Verified date: January 2013
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Genetic Polymorphism
• Healthy Subjects
• Heme Oxygenase

Intervention

Drug:
• saline solution
intravenous infusion, single dose
• heme arginate
intravenous infusion, single dose 0.3 mg/kg heme arginate
• heme arginate
intravenous infusion, single dose 1 mg/kg heme arginate
• heme arginate
intravenous infusion, single dose 3 mg/kg heme arginate

Locations

Country	Name	City	State
Austria	Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Daniel Doberer

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximal HO-1 mRNA expression in PBMCs		2 months	No

External Links

•   Department of Clinical Pharmacology, Medical University of Vienna