Effects of Heme Arginate in Healthy Male Subjects (HEMAHS)

Daniel Doberer

Status and phase: Completed; Phase 1

Conditions: Heme Oxygenase; Healthy Subjects; Genetic Polymorphism

Treatments: Drug: heme arginate; Drug: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT00682370

EudraCT - 2007-003790-11

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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15 participants in 4 patient groups, including a placebo group

A1

Experimental group

Description:

0.3 mg/kg heme arginate

Treatment:

Drug: heme arginate

Drug: heme arginate

Drug: heme arginate

A2

Experimental group

Description:

1 mg/kg heme arginate

Treatment:

Drug: heme arginate

Drug: heme arginate

Drug: heme arginate

A3

Experimental group

Description:

3 mg/kg heme arginate

Treatment:

Drug: heme arginate

Drug: heme arginate

Drug: heme arginate

P

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: saline solution