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

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ClinicalTrials.gov Identifier: NCT00300677
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Sponsor:
Collaborator:
McLean Hospital. Belmont, MA.
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Infections, Fungal Drug: voriconazole Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy
Study Start Date : March 2007
Actual Primary Completion Date : August 2008
Actual Study Completion Date : August 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  2. Brain Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  3. Plasma Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  4. Brain Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]


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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:

  • 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.

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): NCT00300677


Locations
United States, Massachusetts
Pfizer Investigational Site
Belmont, Massachusetts, United States, 02478-1041
Sponsors and Collaborators
Pfizer
McLean Hospital. Belmont, MA.
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00300677     History of Changes
Other Study ID Numbers: A1501079
First Posted: March 9, 2006    Key Record Dates
Results First Posted: October 14, 2009
Last Update Posted: October 14, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
Pharmacokinetics
Voriconazole
Magnetic Resonance Spectroscopy

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