Effects of Heme Arginate in Healthy Male Subjects

Phase 1

Completed

• Conditions: Healthy Subjects; Heme Oxygenase; Genetic Polymorphism
• Interventions: Drug: heme arginate; Drug: saline solution

• Registration Number: NCT00682370
• Lead Sponsor: Daniel Doberer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-21
• Study First Posted: 2008-05-22
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-13
• Last Update Posted: 2013-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A2	heme arginate	1 mg/kg heme arginate
A1	heme arginate	0.3 mg/kg heme arginate
A3	heme arginate	3 mg/kg heme arginate
P	saline solution	Placebo

Primary Outcome Measures

Name	Time	Method
The maximal HO-1 mRNA expression in PBMCs	2 months

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria