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

Candidiasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739934
• Other study ID #: A1501088
• Status: Completed
• Phase: Phase 2
• First received: August 20, 2008
• Last updated: January 26, 2011
• Start date: December 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 11 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Candidemia
• Candidiasis
• Mycoses

Intervention

Drug:
• voriconazole (Vfend)
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)

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Durham	North Carolina
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Nashville	Tennessee
United States	Pfizer Investigational Site	New Orleans	Louisiana
United States	Pfizer Investigational Site	Orange	California
United States	Pfizer Investigational Site	Portland	Oregon
United States	Pfizer Investigational Site	Tucson	Arizona
United States	Pfizer Investigational Site	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Primary	Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration		Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Primary	Time to Reach Cmax (Tmax) Following IV Administration		Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Primary	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.	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No
Primary	Cmax,ss Following Oral Administration		Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No
Primary	Tmax Following Oral Administration		Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No
Secondary	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.	Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	Cmax Following an IV Loading Dose		Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	Tmax Following an IV Loading Dose		Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	Trough Concentrations (Cmin)		Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose	No
Secondary	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.	Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration		Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	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.	Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose	No
Secondary	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.	Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No
Secondary	Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration		Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No
Secondary	Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration		Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose	No

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