Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection

This study has been completed.

Sponsor:

Information provided by:

Pfizer

ClinicalTrials.gov Identifier:

NCT00739934

First received: August 20, 2008

Last updated: January 26, 2011

Last verified: January 2011

History of Changes

Results First Received: September 17, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Pharmacokinetics Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Candidiasis Candidemia
Intervention:	Drug: voriconazole (Vfend)

Participant Flow

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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
All Participants	Voriconazole intravenous (IV) multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

Participant Flow for 2 periods

Period 1: Voriconazole IV

	All Participants
STARTED	40
COMPLETED	34
NOT COMPLETED	6
Adverse Event	6

Period 2: Voriconazole Oral

	All Participants
STARTED	34
COMPLETED	31
NOT COMPLETED	3
unspecified	3

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Voriconazole IV multiple dose (7 mg/kg once every 12 hours) was administered in the morning and evening on Days 1 to 7 (up to Day 20 or more if clinically indicated). The oral maintenance dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).

Baseline Measures

	All Participants
Number of Participants [units: participants]	40
Age, Customized [units: Participants]
2 to <6 years	24
6 to <12 years	16
Gender [units: Participants]
Female	17
Male	23

Outcome Measures

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1. Primary:

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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2. Primary:

Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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3. Primary:

Time to Reach Cmax (Tmax) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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4. Primary:

AUC12,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

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Measure Type	Primary
Measure Title	AUC12,ss Following Oral Administration
Measure Description	AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. AUC12,ss was obtained by the Linear/Log trapezoidal method.
Time Frame	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
ITT population of participants who had completed PK blood sampling for at least one day. N = number of participants with analyzable data.

Reporting Groups

	Description
Voriconazole Oral	Voriconazole oral dose (200 mg) was administered in the morning and evening following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).

Measured Values

	Voriconazole Oral
Number of Participants Analyzed [units: participants]	33
AUC12,ss Following Oral Administration [units: μg*h/mL] Geometric Mean ± Standard Deviation	18.64 ± 50.63

No statistical analysis provided for AUC12,ss Following Oral Administration

5. Primary:

Cmax,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 5

6. Primary:

Tmax Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

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7. Secondary:

AUC12 Following IV Loading Dose [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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8. Secondary:

Cmax Following an IV Loading Dose [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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9. Secondary:

Tmax Following an IV Loading Dose [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

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10. Secondary:

Trough Concentrations (Cmin) [ Time Frame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose ]

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11. Secondary:

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 11

12. Secondary:

Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 12

13. Secondary:

Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 13

14. Secondary:

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 14

15. Secondary:

Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 15

16. Secondary:

Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ]

Show Outcome Measure 16

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 less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 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.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00739934 History of Changes
Other Study ID Numbers:	A1501088
Study First Received:	August 20, 2008
Results First Received:	September 17, 2010
Last Updated:	January 26, 2011
Health Authority:	United States: Food and Drug Administration

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