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To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

This study has been completed.
McLean Hospital. Belmont, MA.
Information provided by:
Pfizer Identifier:
First received: March 7, 2006
Last updated: October 5, 2009
Last verified: October 2009
To determine the amount of voriconazole in the brain after 2 loading doses and 3 maintenance doses over 3 days and compare it to the amount of voriconazole in the plasma.

Condition Intervention Phase
Infections, Fungal
Drug: voriconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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:
  • Plasma Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Brain Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Plasma Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Brain Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]

Enrollment: 12
Study Start Date: March 2007
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: voriconazole
voriconazole twice daily
Drug: voriconazole
Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Other Name: Vfend


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Subjects must be willing and able to provide informed consent.
  • Subjects must be willing and able to be confined at the Clinical Research Unit as required by the protocol.

Exclusion Criteria:

  • Subjects with any condition affecting drug absorption.
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Please refer to this study by its identifier: NCT00300677

United States, Massachusetts
Pfizer Investigational Site
Belmont, Massachusetts, United States, 02478-1041
Sponsors and Collaborators
McLean Hospital. Belmont, MA.
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc Identifier: NCT00300677     History of Changes
Other Study ID Numbers: A1501079
Study First Received: March 7, 2006
Results First Received: August 26, 2009
Last Updated: October 5, 2009

Keywords provided by Pfizer:
Magnetic Resonance Spectroscopy

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 processed this record on April 28, 2017