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
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Pfizer Investigational Site
Belmont, Massachusetts, United States
Plasma Concentrations of Voriconazole
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.
Time frame: Day 3: pre-dose, 2 hours post-dose
Brain Concentrations of Voriconazole
Mean brain concentrations (ng/mL) of voriconazole pre-dose and 2 hours post-dose measured by Fluorine (F) Magnetic Resonance Spectroscopy (F-MRS).
Time frame: Day 3: pre-dose, 2 hours post-dose
Plasma Concentrations of N-oxide Metabolite
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.
Time frame: Day 3: pre-dose, 2 hours post-dose
Brain Concentrations of N-oxide Metabolite
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).
Time frame: Day 3: pre-dose, 2 hours post-dose
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