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Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

This study has been completed.
Sponsor:
Collaborator:
Mclean Hospital
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00136968
First received: August 25, 2005
Last updated: March 10, 2009
Last verified: March 2009
History of Changes
  Purpose

The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.


Condition Intervention Phase
Fungal Infection
 Drug: Voriconazole
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS

Enrollment: 12
Study Start Date: April 2005
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male volunteers 18-55 years of age

Exclusion Criteria:

  • Subjects with any condition affecting drug absorption
  • Subjects with a positive urine drug screen
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00136968

Sponsors and Collaborators
Pfizer
Mclean Hospital
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00136968     History of Changes
Other Study ID Numbers: A1501060
Study First Received: August 25, 2005
Last Updated: March 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Mycoses
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