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

Phase 4

Completed

• Conditions: Infections, Fungal
• Interventions: Drug: voriconazole

• Registration Number: NCT00300677
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-07
• Study First Submitted QC: 2006-03-07
• Study First Posted: 2006-03-09
• Study Start: 2007-03
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-26
• Status Verified: 2009-10
• Results First Submitted QC: 2009-10-05
• Last Update Submitted: 2009-10-05
• Results First Posted: 2009-10-14
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
voriconazole	voriconazole	voriconazole twice daily

Primary Outcome Measures

Name	Time	Method
Plasma Concentrations of Voriconazole	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.
Brain Concentrations of Voriconazole	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).
Plasma Concentrations of N-oxide Metabolite	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.
Brain Concentrations of N-oxide Metabolite	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).

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Belmont, Massachusetts, United States