Effects of Heme Arginate in Healthy Male Subjects

NCT00682370 | Completed Phase 1

• 1 other identifier: EudraCT - 2007-003790-11
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Heme Oxygenase; Genetic Polymorphism

Outcome Measures

Primary Outcomes (1)

• The maximal HO-1 mRNA expression in PBMCs

  2 months

Study Arms (4)

A1

EXPERIMENTAL

0.3 mg/kg heme arginate

Drug: heme arginate

A2

EXPERIMENTAL

1 mg/kg heme arginate

Drug: heme arginate

A3

EXPERIMENTAL

3 mg/kg heme arginate

Drug: heme arginate

P

PLACEBO COMPARATOR

Placebo

Drug: saline solution

Interventions

saline solution DRUG

intravenous infusion, single dose

P

heme arginate DRUG

intravenous infusion, single dose 0.3 mg/kg heme arginate

A1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Daniel Doberer: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Links

• Department of Clinical Pharmacology, Medical University of Vienna

MeSH Terms

Interventions

Saline Solution; heme arginate

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Studienleiter

Study Record Dates

• First Submitted: May 16, 2008
• First Posted: May 22, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: January 15, 2013

Record last verified: 2013-01

Locations

AU (1)