Effects of Heme Arginate in Healthy Male Subjects | NCT00682370

Studies
Effects of Heme Arginate in Healthy Male Subjects

NCT00682370

Sponsor

Daniel Doberer

Status

Completed

Last Update Posted

Jan 15, 2013Estimated

Enrollment

15Actual

Phase

Phase 1

Conditions

Healthy Subjects
Heme Oxygenase
Genetic Polymorphism

Interventions

saline solution
heme arginate
heme arginate
heme arginate

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

May 16, 2008

First Submission Date that Met QC Criteria

May 21, 2008

First Posted Date

May 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2013

Last Update Posted Date

Jan 15, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
saline solution	Drug	intravenous infusion, single dose	P
heme arginate

Measure	Description	Time Frame
The maximal HO-1 mRNA expression in PBMCs		2 months

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D000077330	Saline Solution
C048849	heme arginate

ID	Term
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations