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
  Purpose

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


Condition Intervention Phase
Aspergillosis
Candidemia
Drug: anidulafungin and voriconazole
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Enrollment: 24
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940017

Locations
United States, Connecticut
Pfizer Investigational Site
Hartford, Connecticut, United States, 06102
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
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

Keywords provided by Pfizer:
PK
fungal infection

Additional relevant MeSH terms:
Aspergillosis
Candidemia
Hyalohyphomycosis
Dermatomycoses
Skin Diseases, Infectious
Infection
Mycoses
Skin Diseases
Fungemia
Sepsis
Candidiasis, Invasive
Candidiasis
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Voriconazole
Anidulafungin
Echinocandins
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014