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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00136968
First Posted: August 29, 2005
Last Update Posted: March 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Mclean Hospital
Information provided by:
Pfizer
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Resource links provided by NLM:


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes 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
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): NCT00136968


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

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00136968     History of Changes
Other Study ID Numbers: A1501060
First Submitted: August 25, 2005
First Posted: August 29, 2005
Last Update Posted: March 12, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Mycoses
Voriconazole
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