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Completed

NCT Number: NCT00300677

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

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.

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Key information

Conditions

Infections, Fungal Bacterial Infections and Mycoses Infections Mycoses

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

Pfizer Investigational Site

Belmont, Massachusetts, 02478-1041, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voriconazole

Drug

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

Other names: Vfend

Primary outcomes

  1. Plasma Concentrations of Voriconazole

    Time frame: Day 3: pre-dose, 2 hours post-dose

    Mean plasma voriconazole concentrations (nanograms per milliliter [ng/mL]) pre-dose (Cmin) and two hours post-dose (C2h). Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.

  2. Brain Concentrations of Voriconazole

    Time frame: Day 3: pre-dose, 2 hours post-dose

    Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).

  3. Plasma Concentrations of N-oxide Metabolite

    Time frame: Day 3: pre-dose, 2 hours post-dose

    Mean plasma concentrations of voriconazole N-oxide metabolite (ng/mL) pre-dose and 2 hours post-dose. Plasma samples were assayed using a validated, sensitive, and specific high performance liquid chromatography/tandem mass spectrometry (HPLC-MS/MS) method.

  4. Brain Concentrations of N-oxide Metabolite

    Time frame: Day 3: pre-dose, 2 hours post-dose

    Mean brain concentrations (ng/mL) of voriconazole N-oxide metabolite pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • McLean Hospital. Belmont, MA.

Registry information

Official study title

Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 9, 2006
Registry last updated
Oct 14, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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