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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014