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.
Sponsor:
Collaborator:
McLean Hospital. Belmont, MA.
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00300677
First received: March 7, 2006
Last updated: October 5, 2009
Last verified: October 2009
  Purpose

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
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]
  • Brain Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]
  • Plasma Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]
  • Brain Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Pharmacokinetics
Voriconazole
Magnetic Resonance Spectroscopy

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 20, 2014