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

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ClinicalTrials.gov Identifier: NCT00175994
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : April 17, 2007
Information provided by:
Heidelberg University

Brief Summary:

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 or disease Phase
Healthy Phase 1

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.

Study Type : Observational
Estimated Enrollment : 24 participants
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
Study Start Date : July 2005
Study Completion Date : July 2006

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U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175994

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

ClinicalTrials.gov Identifier: NCT00175994     History of Changes
Other Study ID Numbers: 2005-001649-41
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: April 17, 2007
Last Verified: April 2007

Keywords provided by Heidelberg University:
metabolic clearance

Additional relevant MeSH terms:
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors