A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00940017
First received: July 13, 2009
Last updated: January 5, 2010
Last verified: January 2010
Results First Received: October 20, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label
Conditions: Aspergillosis
Candidemia
Intervention: Drug: anidulafungin and voriconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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
Anidulafungin and Voriconazole Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.

Participant Flow:   Overall Study
    Anidulafungin and Voriconazole  
STARTED     24  
Subjects Treated     21  
COMPLETED     20  
NOT COMPLETED     4  
did not meet entrance criteria                 3  
Adverse Event                 1  



  Baseline Characteristics
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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
Anidulafungin and Voriconazole Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.

Baseline Measures
    Anidulafungin and Voriconazole  
Number of Participants  
[units: participants]
  24  
Age  
[units: years]
Mean ± Standard Deviation
  27.3  ± 7.8  
Gender  
[units: participants]
 
Female     5  
Male     19  



  Outcome Measures
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1.  Primary:   Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

2.  Primary:   Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

3.  Primary:   Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

4.  Primary:   Plasma PK: Plasma Elimination Half-life (t1/2)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

5.  Primary:   Plasma PK: Total Clearance (CL Total)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

6.  Primary:   Plasma PK: Volume of Distribution at Steady-state (Vss)   [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]

7.  Primary:   Epithelial Lining Fluid (ELF) PK: Cmax   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

8.  Primary:   ELF PK: Tmax   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

9.  Primary:   ELF PK: AUCtau   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

10.  Primary:   ELF PK: t1/2   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

11.  Primary:   Alveolar Macrophages (AM): Cmax   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

12.  Primary:   AM: Tmax   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

13.  Primary:   AM: AUCtau   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

14.  Primary:   AM: t1/2   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

15.  Primary:   Overall Drug Penetration Ratio in ELF   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]

16.  Primary:   Concentration Ratio in ELF to Plasma   [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.


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.  


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


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00940017     History of Changes
Other Study ID Numbers: A8851020
Study First Received: July 13, 2009
Results First Received: October 20, 2009
Last Updated: January 5, 2010
Health Authority: United States: Food and Drug Administration