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

Infections, Fungal 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: NCT00300677
• Other study ID #: A1501079
• Status: Completed
• Phase: Phase 4
• First received: March 7, 2006
• Last updated: October 5, 2009
• Start date: March 2007
• Est. completion date: August 2008

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Infections, Fungal
• Mycoses

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Belmont	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Pfizer	McLean Hospital. Belmont, MA.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Concentrations of Voriconazole		Day 3: pre-dose, 2 hours post-dose	No
Primary	Brain Concentrations of Voriconazole		Day 3: pre-dose, 2 hours post-dose	No
Primary	Plasma Concentrations of N-oxide Metabolite		Day 3: pre-dose, 2 hours post-dose	No
Primary	Brain Concentrations of N-oxide Metabolite		Day 3: pre-dose, 2 hours post-dose	No

External Links

•   To obtain contact information for a study center near you, click here.