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Bioavailability and Metabolism of Voriconazole in Relation to Its Modulation by the CYP2C19 Genetic Polymorphism

This study has been completed.
Sponsor:
Information provided by:
University of Heidelberg
ClinicalTrials.gov Identifier:
NCT00175994
First received: September 12, 2005
Last updated: April 16, 2007
Last verified: April 2007
History of Changes
  Purpose

The purposes of this study are:

  • To determine the absolute bioavailability of voriconazole after a single oral dose (400 mg voriconazole [VFEND brand]) in comparison to intravenous (i.v.) administration (400 mg VFEND, equivalent to two 10 mg/ml-infusates, each containing 200 mg voriconazole [VRC]) in healthy individuals stratified according to the three predominant CYP2C19 genotypes
  • To investigate the possible pathways of metabolism and their modulation according to genetic polymorphism of CYP2C19 after i.v. and oral administration of VRC.

Condition Phase
Healthy
 Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Bioavailability and Metabolism of Voriconazole as a Function of the CYP2C19 Genotype

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Heidelberg:

Estimated Enrollment: 24
Study Start Date: July 2005
Study Completion Date: July 2006
Detailed Description:

As CYPs are mainly involved in VRC metabolism it is likely that also gut wall metabolism by CYPs occurs. However, no substantial first pass metabolism of VRC has been reported. In humans the VRC metabolism has not been studied systematically. It is therefore important to assess VRC metabolism on its own and in addition the influence of CYP2C19 genetic polymorphisms on the formation of the different VRC metabolites.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good state of health (physically and mentally)

Exclusion Criteria:

  • Any regular drug treatment within the last two months except for oral contraceptives in female participants
  • Any intake of a substance known to induce or inhibit drug metabolising enzymes or transport system enzymes within a period of less than 10 times the respective elimination half-life
  • Any acute or chronic illness or clinically relevant findings in the pre-study examination
  • Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions
  • Smoking (regular or irregular)
  • Excessive alcohol drinking (more than approximately 30 g alcohol per day)
  • Positive drug screening or known or admitted drug abuse
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00175994

Locations
Germany
Clinical Research Unit, Department Internal Medicine VI
Heidelberg, Germany, 69120
Sponsors and Collaborators
University of Heidelberg
Investigators
Principal Investigator: Gerd Mikus, MD BSc Department Internal Medicine VI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00175994     History of Changes
Other Study ID Numbers: 2005-001649-41, K117
Study First Received: September 12, 2005
Last Updated: April 16, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Heidelberg:
voriconazole
genotype
bioavailability
metabolic clearance

Additional relevant MeSH terms:
Voriconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013