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

Aspergillosis Clinical Trial

Official title:

A Phase 4, Open Label Study To Assess The Bronchopulmonary Pharmacokinetics Of Anidulafungin And Voriconazole Following Intravenous Administration In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940017
• Other study ID #: A8851020
• Status: Completed
• Phase: Phase 4
• First received: July 13, 2009
• Last updated: January 5, 2010
• Start date: September 2008
• Est. completion date: October 2008

Study information

• Verified date: January 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Aspergillosis
• Candidemia

Intervention

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.

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma Pharmacokinetics (PK): Maximum Observed Plasma Concentration (Cmax)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Plasma PK: Time to Reach Maximum Plasma Concentration (Tmax)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Plasma PK: Area Under the Curve From Time Zero to Time = Tau (AUCtau)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Plasma PK: Plasma Elimination Half-life (t1/2)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Plasma PK: Total Clearance (CL Total)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Plasma PK: Volume of Distribution at Steady-state (Vss)		100 minutes (end of infusion), 2, 4, 8, 12, 24 hours after start of infusion	No
Primary	Epithelial Lining Fluid (ELF) PK: Cmax		4, 8, 12, 24 hours after start of infusion	No
Primary	ELF PK: Tmax		4, 8, 12, 24 hours after start of infusion	No
Primary	ELF PK: AUCtau		4, 8, 12, 24 hours after start of infusion	No
Primary	ELF PK: t1/2		4, 8, 12, 24 hours after start of infusion	No
Primary	Alveolar Macrophages (AM): Cmax		4, 8, 12, 24 hours after start of infusion	No
Primary	AM: Tmax		4, 8, 12, 24 hours after start of infusion	No
Primary	AM: AUCtau		4, 8, 12, 24 hours after start of infusion	No
Primary	AM: t1/2		4, 8, 12, 24 hours after start of infusion	No
Primary	Overall Drug Penetration Ratio in ELF		4, 8, 12, 24 hours after start of infusion	No
Primary	Concentration Ratio in ELF to Plasma		4, 8, 12, 24 hours after start of infusion	No

External Links

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