NCT00136968

Brief Summary

The purpose of this study is to determine the amount of voriconazole in the brain by fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.

Trial Health

100
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_1

Timeline
Completed

Started Apr 2005

Shorter than P25 for phase_1

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

Study Start

First participant enrolled

April 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
Last Updated

March 12, 2009

Status Verified

March 1, 2009

First QC Date

August 25, 2005

Last Update Submit

March 10, 2009

Conditions

Fungal Infection

Outcome Measures

Primary Outcomes (1)

  • Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS

Interventions

VoriconazoleDRUG

Eligibility Criteria

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

You may qualify if:

  • Healthy male volunteers 18-55 years of age

You may not qualify if:

  • Subjects with any condition affecting drug absorption
  • Subjects with a positive urine drug screen

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Mycoses

Interventions

Voriconazole

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

April 1, 2005

Study Completion

May 1, 2005

Last Updated

March 12, 2009

Record last verified: 2009-03