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

Verified by: Pfizer, October 2009
First Received: March 7, 2006 | Last Updated: October 5, 2009 | Phase: Phase 4 | Start Date: March 2007
Overall Status: Completed | Estimated Enrollment: 12
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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...

Brief Summary

Official Title: “Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
  • Study Primary Completion Date: August 2008

Intervention(s) in this Clinical Trial

  • Drug: voriconazole
    • Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: voriconazole
    • voriconazole twice daily

Outcome Measures for this Clinical Trial

Primary Measures

  • Plasma Concentrations of Voriconazole
    • Time Frame: Day 3: pre-dose, 2 hours post-dose
      Safety Issue?: No
  • Brain Concentrations of Voriconazole
    • Time Frame: Day 3: pre-dose, 2 hours post-dose
      Safety Issue?: No
  • Plasma Concentrations of N-oxide Metabolite
    • Time Frame: Day 3: pre-dose, 2 hours post-dose
      Safety Issue?: No
  • Brain Concentrations of N-oxide Metabolite
    • Time Frame: Day 3: pre-dose, 2 hours post-dose
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 55 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Pfizer Industry

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300677

Study ID Number: A1501079

ClinicalTrials.gov Identifier: NCT00300677

Health Authority: United States: Food and Drug Administration

To obtain contact information for a study center near you, click here.

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