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Trial record 1 of 1 for:    NCT00300677
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To Determine The Amount Of Voriconazole In The Brain After 2 Loading Doses And 3 Maintenance Doses Over 3 Days

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00300677
Recruitment Status : Completed
First Posted : March 9, 2006
Results First Posted : October 14, 2009
Last Update Posted : October 14, 2009
Sponsor:
Collaborator:
McLean Hospital. Belmont, MA.
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 7, 2006
First Posted Date  ICMJE March 9, 2006
Results First Submitted Date  ICMJE August 26, 2009
Results First Posted Date  ICMJE October 14, 2009
Last Update Posted Date October 14, 2009
Study Start Date  ICMJE March 2007
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
  • Plasma Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Brain Concentrations of Voriconazole [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Plasma Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
  • Brain Concentrations of N-oxide Metabolite [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]
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 Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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 Arms  ICMJE Experimental: voriconazole
voriconazole twice daily
Intervention: Drug: voriconazole
Publications * 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.

*   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: March 7, 2006)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2008
Actual 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.
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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00300677
Other Study ID Numbers  ICMJE A1501079
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
PRS Account Pfizer
Verification Date October 2009

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