Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Fungal Infection Clinical Trial

Official title:

Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00136968
• Other study ID #: A1501060
• Status: Completed
• Phase: Phase 1
• First received: August 25, 2005
• Last updated: March 10, 2009
• Start date: April 2005
• Est. completion date: May 2005

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Healthy male volunteers 18-55 years of age

Exclusion Criteria:

• Subjects with any condition affecting drug absorption

• Subjects with a positive urine drug screen

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Fungal Infection
• Mycoses

Intervention

Drug:
• Voriconazole

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	Mclean Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess brain levels of voriconazole in the brain using a non-evasive technique of MRS