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

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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

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Infections, Fungal
Intervention: Drug: voriconazole

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Healthy male volunteers were recruited by 1 hospital center in the U.S. between March 2007 and August 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Voriconazole 400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3

Participant Flow:   Overall Study
    Voriconazole
STARTED   12 
COMPLETED   12 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Voriconazole 400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3

Baseline Measures
   Voriconazole 
Overall Participants Analyzed 
[Units: Participants]
 12 
Age, Customized 
[Units: Participants]
 
18-25 years   3 
26-35 years   6 
36-45 years   3 
Gender 
[Units: Participants]
 
Female   0 
Male   12 


  Outcome Measures

1.  Primary:   Plasma Concentrations of Voriconazole   [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]

2.  Primary:   Brain Concentrations of Voriconazole   [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]

3.  Primary:   Plasma Concentrations of N-oxide Metabolite   [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]

4.  Primary:   Brain Concentrations of N-oxide Metabolite   [ Time Frame: Day 3: pre-dose, 2 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.govCallCenter@pfizer.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00300677     History of Changes
Other Study ID Numbers: A1501079
First Submitted: March 7, 2006
First Posted: March 9, 2006
Results First Submitted: August 26, 2009
Results First Posted: October 14, 2009
Last Update Posted: October 14, 2009