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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00739934
First received: August 20, 2008
Last updated: January 26, 2011
Last verified: January 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Candidiasis Candidemia |
Drug: voriconazole (Vfend) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]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 Frame: Day 7 (up to Day 20 or more) at predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- AUC12,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]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 [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- Tmax Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- AUC12 Following IV Loading Dose [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]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 [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- Tmax Following an IV Loading Dose [ Time Frame: Day 1 predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- Trough Concentrations (Cmin) [ Time Frame: Day 7 (up to Day 20 or more) for IV; Day 7 (or later) for oral at predose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 [ Time Frame: Days 1 and 7 (up to Day 20 or more) predose, 60 and 138 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]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 [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]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 [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 40 |
| Study Start Date: | December 2008 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Children aged 2 to <12 years
Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection.
|
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:
(IV = Intravenous; POS = Powder for oral suspension) Other Name: UK-109,496; Vfend; voriconazole
|
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00739934
Locations
| United States, Arizona | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85719 | |
| Pfizer Investigational Site | |
| Tucson, Arizona, United States, 85724 | |
| United States, California | |
| Pfizer Investigational Site | |
| Orange, California, United States, 92868 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Jacksonville, Florida, United States, 32207 | |
| United States, Georgia | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30322 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30322-1062 | |
| Pfizer Investigational Site | |
| Atlanta, Georgia, United States, 30342-1600 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, Maryland | |
| Pfizer Investigational Site | |
| Baltimore, Maryland, United States, 21215 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
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 |
Keywords provided by Pfizer:
|
Open-Label Pharmacokinetics Intravenous to oral switch Safety |
Voriconazole Immunocompromise Children High Risk For Systemic Fungal Infection. |
Additional relevant MeSH terms:
|
Candidiasis Mycoses Candidemia Fungemia Sepsis Infection Candidiasis, Invasive Systemic Inflammatory Response Syndrome Inflammation |
Pathologic Processes Voriconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013