NCT00895167

Brief Summary

Heme oxygenase 1 (HO-1) serves as a protective gene. Induction of HO-1 has therapeutic potential for several indications. The inducibility of HO-1 by curcumin will be evaluated in this pilot study. Furthermore, the influence of a modulating factor of HO-1 gene activity on the dinucleotide guanosine thymine repeat (GT) length polymorphism in the promotor region will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 8, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

January 17, 2013

Status Verified

January 1, 2013

Enrollment Period

6 months

First QC Date

May 6, 2009

Last Update Submit

January 16, 2013

Conditions

Healthy

Keywords

Heme OxygenaseGenetic PolymorphismHealthy Subjects

Outcome Measures

Primary Outcomes (1)

  • The maximal HO-1 mRNA expression and HO-1 protein level in PBMCs

    48 hrs

Secondary Outcomes (1)

  • Increase of plasma bilirubin level

    48 hrs

Study Arms (1)

curcumin

EXPERIMENTAL

every subject receives 12 g of oral curcumin

Dietary Supplement: curcumin

Interventions

curcuminDIETARY_SUPPLEMENT

one oral dose of 12 caplets = 12 g curcumin

Also known as: Curcumin C3 Complex caplets containing:, 1000 mg curcumin and 5 mg bioperine, Lot. Nr.: #BA 08072227
curcumin

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Signed informed consent prior to any study-mandated procedure.
  • Male patient 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 weeks 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.
  • Regularly intake of curcumin rich food
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of Clinical Pharmacology

Vienna, 1090, Austria

Location

Related Links

MeSH Terms

Interventions

Curcumin

Intervention Hierarchy (Ancestors)

DiarylheptanoidsHeptanesAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, Cyclic

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Subinvestigator

Study Record Dates

First Submitted

May 6, 2009

First Posted

May 8, 2009

Study Start

January 1, 2009

Primary Completion

July 1, 2009

Study Completion

August 1, 2009

Last Updated

January 17, 2013

Record last verified: 2013-01

Locations

AU(1)