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

Primary Purpose

Candidiasis, Candidemia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
voriconazole (Vfend)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Candidiasis focused on measuring Open-Label, Pharmacokinetics, Intravenous to oral switch, Safety, Voriconazole, Immunocompromise, Children, High Risk For Systemic Fungal Infection.

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female from 2 to <12 years of age.
  • Require treatment for the prevention of systemic fungal infection.
  • Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy.
  • Anticipated to live for more than 3 months.

Exclusion Criteria:

  • Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia.
  • Documented bacterial or viral infection not responding to appropriate treatment.
  • Hypersensitivity to or severe intolerance of azole antifungal agents.
  • Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Children aged 2 to <12 years

Arm Description

Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection.

Outcomes

Primary Outcome Measures

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
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.
Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
Time to Reach Cmax (Tmax) Following IV Administration
AUC12,ss Following Oral Administration
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.
Cmax,ss Following Oral Administration
Tmax Following Oral Administration

Secondary Outcome Measures

AUC12 Following IV Loading Dose
AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
Cmax Following an IV Loading Dose
Tmax Following an IV Loading Dose
Trough Concentrations (Cmin)
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
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.
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
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.
Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

Full Information

First Posted
August 20, 2008
Last Updated
January 26, 2011
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00739934
Brief Title
Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection
Official Title
An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To <12 Years Who Are At High Risk For Systemic Fungal Infection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to 12 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Candidiasis, Candidemia
Keywords
Open-Label, Pharmacokinetics, Intravenous to oral switch, Safety, Voriconazole, Immunocompromise, Children, High Risk For Systemic Fungal Infection.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Children aged 2 to <12 years
Arm Type
Experimental
Arm Description
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection.
Intervention Type
Drug
Intervention Name(s)
voriconazole (Vfend)
Other Intervention Name(s)
UK-109,496; Vfend; voriconazole
Intervention Description
Study Days 1 to 7: IV voriconazole 7 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h Notes: If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose. Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30. (IV = Intravenous; POS = Powder for oral suspension)
Primary Outcome Measure Information:
Title
Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
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 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
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
Title
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
Title
AUC12,ss Following Oral Administration
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
Title
Cmax,ss Following Oral Administration
Time Frame
Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Title
Tmax Following Oral Administration
Time Frame
Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose
Secondary Outcome Measure Information:
Title
AUC12 Following IV Loading Dose
Description
AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
Time Frame
Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
Cmax Following an IV Loading Dose
Time Frame
Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
Tmax Following an IV Loading Dose
Time Frame
Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
Trough Concentrations (Cmin)
Time Frame
Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose
Title
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
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
Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
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
Title
Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
Description
Zero Tmax refers to the highest concentration observed for one participant at predose. The profile of the metabolite is relatively flat, which could result in slight variation in sample collection or assay process.
Time Frame
Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose
Title
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female from 2 to <12 years of age. Require treatment for the prevention of systemic fungal infection. Expected to develop neutropenia (ANC <500 cells/μL) lasting more than 10 days following chemotherapy. Anticipated to live for more than 3 months. Exclusion Criteria: Evidence of any clinically significant liver or renal function or other abnormalities such as cardiac arrhythmia, hypokalemia, hypomagnesemia or hypocalcemia. Documented bacterial or viral infection not responding to appropriate treatment. Hypersensitivity to or severe intolerance of azole antifungal agents. Receiving other azoles or drugs that is are prohibited in the voriconazole label or associated.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Pfizer Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
Pfizer Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pfizer Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1062
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Pfizer Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-1600
Country
United States
Facility Name
Pfizer Investigational Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Pfizer Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Pfizer Investigational Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Pfizer Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Pfizer Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Pfizer Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1501088&StudyName=Study%20Of%20The%20Pharmacokinetics%20And%20Safety%20Of%20Voriconazole%20In%20Children%202%20To%2011%20Years%20Old%20Who%20Are%20At%20High%20Risk%20For%20Systemic%20Fungal%20
Description
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Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To 11 Years Old Who Are At High Risk For Systemic Fungal Infection

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