Effects of Heme Arginate in Healthy Male Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Subjects Heme Oxygenase Genetic Polymorphism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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A1

0.3 mg/kg heme arginate

Group Type EXPERIMENTAL

heme arginate

Intervention Type DRUG

intravenous infusion, single dose

0.3 mg/kg heme arginate

A2

1 mg/kg heme arginate

Group Type EXPERIMENTAL

heme arginate

Intervention Type DRUG

intravenous infusion, single dose

1 mg/kg heme arginate

A3

3 mg/kg heme arginate

Group Type EXPERIMENTAL

heme arginate

Intervention Type DRUG

intravenous infusion, single dose

3 mg/kg heme arginate

P

Placebo

Group Type PLACEBO_COMPARATOR

saline solution

Intervention Type DRUG

intravenous infusion, single dose

Interventions

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saline solution

intravenous infusion, single dose

Intervention Type DRUG

heme arginate

intravenous infusion, single dose

0.3 mg/kg heme arginate

Intervention Type DRUG

heme arginate

intravenous infusion, single dose

1 mg/kg heme arginate

Intervention Type DRUG

heme arginate

intravenous infusion, single dose

3 mg/kg heme arginate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes