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Trial record 36 of 58 for:    "Aspergillosis" | "Cytochrome P-450 CYP3A Inhibitors"

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

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ClinicalTrials.gov Identifier: NCT00940017
Recruitment Status : Completed
First Posted : July 15, 2009
Results First Posted : February 9, 2010
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE July 13, 2009
First Posted Date  ICMJE July 15, 2009
Results First Submitted Date  ICMJE October 20, 2009
Results First Posted Date  ICMJE February 9, 2010
Last Update Posted Date February 9, 2010
Study Start Date  ICMJE September 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2010)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Plasma PK: Total Clearance (CL Total) [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ]
  • 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 ]
  • Epithelial Lining Fluid (ELF) PK: Cmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • ELF PK: Tmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • ELF PK: AUCtau [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • ELF PK: t1/2 [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • Alveolar Macrophages (AM): Cmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • AM: Tmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • AM: AUCtau [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • AM: t1/2 [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • Overall Drug Penetration Ratio in ELF [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
  • Concentration Ratio in ELF to Plasma [ Time Frame: 4, 8, 12, 24 hours after start of infusion ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
PK: AUC, Cmax, Tmax etc in plasma, ELF and AM [ Time Frame: 2 months ]
Change History Complete list of historical versions of study NCT00940017 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2009)
Safety: Safety laboratory tests, vital signs, physical exam results and adverse event monitoring [ Time Frame: 2 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
Official Title  ICMJE A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects
Brief Summary The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE
  • Aspergillosis
  • Candidemia
Intervention  ICMJE Drug: anidulafungin and voriconazole
Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: anidulafungin and voriconazole
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: July 14, 2009)
24
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult subjects willing to comply with the study requirement.

Exclusion Criteria:

  • Clinical significant disease.
  • Sensitive to study medication.
  • Not willing to comply with the study requirement.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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 NCT00940017
Other Study ID Numbers  ICMJE A8851020
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 Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2010

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