NCT00300677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2006

Completed
12 months until next milestone

Study Start

First participant enrolled

March 1, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

October 14, 2009

Completed
Last Updated

October 14, 2009

Status Verified

October 1, 2009

Enrollment Period

1.4 years

First QC Date

March 7, 2006

Results QC Date

August 26, 2009

Last Update Submit

October 5, 2009

Conditions

Infections, Fungal

Keywords

PharmacokineticsVoriconazoleMagnetic Resonance Spectroscopy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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).

    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.

    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).

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

Study Arms (1)

voriconazole

EXPERIMENTAL

voriconazole twice daily

Drug: voriconazole

Interventions

voriconazoleDRUG

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

Also known as: Vfend
voriconazole

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Subjects with any condition affecting drug absorption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Belmont, Massachusetts, 02478-1041, United States

Location

Related Publications (1)

  • 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.

    PMID: 23939898DERIVED

Related Links

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.govCallCenter@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 7, 2006

First Posted

March 9, 2006

Study Start

March 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

October 14, 2009

Results First Posted

October 14, 2009

Record last verified: 2009-10

Locations

US(1)