Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection

Study Of The Pharmacokinetics And Safety Of Voriconazole In Children 2 To Less Than 15 Years Old Who Are At High Risk For Systemic Fungal Infection
This study is currently recruiting participants.
Verified August 2012 by Pfizer

First Received on June 27, 2011.  
Last Updated on August 1, 2012  
History of Changes
Sponsor: Pfizer
Information provided by (Responsible Party): Pfizer
ClinicalTrials.gov Identifier: NCT01383993
  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 less than 15 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
Aspergillosis, Aspergilloma
Candidemia, Candidiasis
Cryptococcal Meningitis, Pulmonary Cryptococcosis
Fusariosis
Scedosporiosis
Drug: Voriconazole Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open-Label, Non-Controlled, Multicenter, Intravenous To Oral Switch, Phase 2 Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Children Aged 2 To Less Than 15 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 AUC12,ss = Area under the plasma concentration-time profile from time zero (predose) to twelve hours at steady-state. [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
  • 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 162 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 162 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 postdos ] [ Designated as safety issue: No ]
  • Cmax,ss Following Oral Administration [ Time Frame: Day 7 (or later) predose, 1, 2, 4, 6, 8 and 12 hours postdos ] [ 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:

  • Ratio of AUC12,ss Following IV Administration and AUC12,ss Following Oral Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
  • AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
  • Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 7 (up to Day 20 or more) at predose, 60 and 162 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: Day 7 (up to Day 20 or more) at predose, 60 and 162 minutes, 4, 6, 8 and 12 hours postdose ] [ Designated as safety issue: No ]
  • 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 ]
  • 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 ]

Estimated Enrollment: 20
Study Start Date: August 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Interventions
Experimental: 1.0

Immunocompromised children aged 2 to <15 and 12 to <15 years weighing <50 kg who are at high risk for systemic fungal infection.
Drug: Voriconazole

Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.

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)

Other Name: UK-109,496; Vfend; Voriconazole
Experimental: 2.0

Immunocompromised children aged 12 to <15 years weighing more than 50 kg who are at high risk for systemic fungal infection.
Drug: Voriconazole

Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 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)

Other Name: UK-109,496; Vfend; Voriconazole

  Eligibility

Ages Eligible for Study:   2 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female from 2 to <15 years of age.
  • Require treatment for the prevention of systemic fungal infection.
  • Expected to develop neutropenia (ANC <500 cells/uL) 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: NCT01383993

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Japan
National hospital Organization Nagoya Medical Center Recruiting
Nagoya, Aichi, Japan
Japanese Red Cross Nagoya Daiichi Hospital Recruiting
Nagoya, Aichi, Japan
Sapporo Hokuyu Hosipital Recruiting
Sapporo, Hokkaido, Japan
Kanagawa Children’s Medical Center Recruiting
Yokohama, Kanagawa, Japan
Osaka Medical Center and Research Institute for Maternal and Child Health Not yet recruiting
Izumi, Osaka, Japan
Dokkyo Medical University Hospital Recruiting
Shimotsuga-gun, Tochigi, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01383993    
History of Changes
Other Study ID Numbers: A1501096
Study First Received: June 27, 2011
Last Updated: August 1, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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:

Aspergillosis
Candidiasis
Cryptococcosis
Meningitis
Mycoses
Meningitis, Cryptococcal
Candidemia
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Fungal
Central Nervous System Fungal Infections
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 August 21, 2012

Leave a Reply

You can use these HTML tags

<a href="" title=""> <abbr title=""> <acronym title=""> <b> <blockquote cite=""> <cite> <code> <del datetime=""> <em> <i> <q cite=""> <s> <strike> <strong>

  

  

  

fifteen + nine =