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

This study has been completed.

Sponsor:

Collaborator:

McLean Hospital. Belmont, MA.

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00300677

First received: March 7, 2006

Last updated: October 5, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

March 7, 2006

Last Updated Date

October 5, 2009

Start Date ^ICMJE

March 2007

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Plasma Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]
Brain Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]
Plasma Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]
Brain Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00300677 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Assessment Of Voriconazole Penetration Into The Brain By Fluorine-Magnetic Resonance Spectroscopy

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

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

Condition ^ICMJE

Infections, Fungal

Intervention ^ICMJE

Drug: voriconazole

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

Other Name: Vfend

Study Arm (s)

Experimental: voriconazole

voriconazole twice daily

Intervention: Drug: voriconazole

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years to 55 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00300677

Other Study ID Numbers ^ICMJE

A1501079

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer Inc

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

McLean Hospital. Belmont, MA.

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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