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

July 13, 2009
January 5, 2010
September 2008
October 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Plasma PK: Total Clearance (CL Total) [ Time Frame: 100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Epithelial Lining Fluid (ELF) PK: Cmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • ELF PK: Tmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • ELF PK: AUCtau [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • ELF PK: t1/2 [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • Alveolar Macrophages (AM): Cmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • AM: Tmax [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • AM: AUCtau [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • AM: t1/2 [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • Overall Drug Penetration Ratio in ELF [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
  • Concentration Ratio in ELF to Plasma [ Time Frame: 4, 8, 12, 24 hours after start of infusion ] [ Designated as safety issue: No ]
PK: AUC, Cmax, Tmax etc in plasma, ELF and AM [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00940017 on ClinicalTrials.gov Archive Site
Not Provided
Safety: Safety laboratory tests, vital signs, physical exam results and adverse event monitoring [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study To Assess The Anidulafungin And Voriconazole Concentration In Lung Following Intravenous Administration In Healthy Subjects
A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects

The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Aspergillosis
  • Candidemia
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.
Experimental: 1
Intervention: Drug: anidulafungin and voriconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00940017
A8851020
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
January 2010

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