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

Last updated on November 9, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Fungal Infection
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male volunteers 18-55 years of age

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with any condition affecting drug absorption

- Subjects with a positive urine drug screen

NCT00136968
Pfizer
Completed
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy

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Descriptive Information
Brief Title  ICMJE Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
Official Title  ICMJE Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
Brief SummaryThe 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.
Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Fungal Infection
Intervention  ICMJE Drug: Voriconazole
Study Arms  ICMJE Not Provided
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
Actual Enrollment  ICMJE
 (submitted: August 25, 2005)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2005
Primary Completion DateNot Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00136968
Other Study ID Numbers  ICMJE A1501060
Has Data Monitoring CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Mclean Hospital
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2009

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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