search
Back to results

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

Primary Purpose

Infections, Fungal

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
voriconazole
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Infections, Fungal focused on measuring Pharmacokinetics, Voriconazole, Magnetic Resonance Spectroscopy

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

voriconazole

Arm Description

voriconazole twice daily

Outcomes

Primary Outcome Measures

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.
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).
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.
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).

Secondary Outcome Measures

Full Information

First Posted
March 7, 2006
Last Updated
October 5, 2009
Sponsor
Pfizer
Collaborators
McLean Hospital. Belmont, MA.
search

1. Study Identification

Unique Protocol Identification Number
NCT00300677
Brief Title
To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days
Official Title
Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer
Collaborators
McLean Hospital. Belmont, MA.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Fungal
Keywords
Pharmacokinetics, Voriconazole, Magnetic Resonance Spectroscopy

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
voriconazole
Arm Type
Experimental
Arm Description
voriconazole twice daily
Intervention Type
Drug
Intervention Name(s)
voriconazole
Other Intervention Name(s)
Vfend
Intervention Description
Multiple oral doses of voriconazole at 400 mg loading twice daily followed by 200 mg maintenance twice daily
Primary Outcome Measure Information:
Title
Plasma Concentrations of Voriconazole
Description
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
Title
Brain Concentrations of Voriconazole
Description
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
Title
Plasma Concentrations of N-oxide Metabolite
Description
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
Title
Brain Concentrations of N-oxide Metabolite
Description
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478-1041
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23939898
Citation
Henry ME, Bolo NR, Zuo CS, Villafuerte RA, Cayetano K, Glue P, Damle BD, Andrews E, Lauriat TL, Rana NS, Churchill JH, Renshaw PF. Quantification of brain voriconazole levels in healthy adults using fluorine magnetic resonance spectroscopy. Antimicrob Agents Chemother. 2013 Nov;57(11):5271-6. doi: 10.1128/AAC.00394-13. Epub 2013 Aug 12.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501079&StudyName=To%20Determine%20The%20Amount%20Of%20Voriconazole%20In%20The%20Brain%20After%202%20Loading%20Doses%20And%203%20Maintenance%20Doses%20Over%203%20Days%20
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs