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

NCT ID: NCT00300677

Last Updated: 2009-10-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2008-08-31

Brief Summary

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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

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Conditions

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Infections, Fungal

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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voriconazole

voriconazole twice daily

Group Type EXPERIMENTAL

voriconazole

Intervention Type DRUG

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

Interventions

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voriconazole

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

Intervention Type DRUG

Other Intervention Names

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Vfend

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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McLean Hospital. Belmont, MA.

UNKNOWN

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Belmont, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 23939898 (View on PubMed)

Related Links

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Other Identifiers

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A1501079

Identifier Type: -

Identifier Source: org_study_id

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