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

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

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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.

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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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.

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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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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 ]

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7. Primary:

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

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8. Primary:

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

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9. Primary:

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

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10. Primary:

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

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11. Primary:

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

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12. Primary:

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

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13. Primary:

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

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14. Primary:

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

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15. Primary:

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

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16. Primary:

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

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Serious Adverse Events

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Other Adverse Events

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of < 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), < 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

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
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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