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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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Candidiasis; Candidemia

Intervention: voriconazole (Vfend) (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Clinical Details

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

Primary outcome:

Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration

Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration

Time to Reach Cmax (Tmax) Following IV Administration

AUC12,ss Following Oral Administration

Cmax,ss Following Oral Administration

Tmax Following Oral Administration

Secondary outcome:

AUC12 Following IV Loading Dose

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

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

AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration

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

Eligibility

Minimum age: 2 Years. Maximum age: 11 Years. Gender(s): Both.

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.

Locations and Contacts

Pfizer Investigational Site, Tucson, Arizona 85719, United States

Pfizer Investigational Site, Tucson, Arizona 85724, United States

Pfizer Investigational Site, Orange, California 92868, United States

Pfizer Investigational Site, Jacksonville, Florida 32207, United States

Pfizer Investigational Site, Atlanta, Georgia 30322-1062, United States

Pfizer Investigational Site, Atlanta, Georgia 30322, United States

Pfizer Investigational Site, Atlanta, Georgia 30342-1600, United States

Pfizer Investigational Site, New Orleans, Louisiana 70118, United States

Pfizer Investigational Site, Baltimore, Maryland 21215, United States

Pfizer Investigational Site, Durham, North Carolina 27710, United States

Pfizer Investigational Site, Cleveland, Ohio 44106, United States

Pfizer Investigational Site, Portland, Oregon 97239, United States

Pfizer Investigational Site, Nashville, Tennessee 37232, United States

Pfizer Investigational Site, Houston, Texas 77030, United States

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2008
Last updated: January 26, 2011

Page last updated: August 23, 2015

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