A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00556998
First received: November 9, 2007
Last updated: February 27, 2012
Last verified: February 2012

November 9, 2007
February 27, 2012
June 2008
December 2009   (final data collection date for primary outcome measure)
  • Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration [ Time Frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ 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) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • Time to Reach Cmax (Tmax) Following IV Administration [ Time Frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • AUC12,ss Following Oral Administration [ Time Frame: Day 7 (up to Day 30) at 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 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
  • Tmax Following Oral Administration [ Time Frame: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
Pharmacokinetic parameters of voriconazole in adolescents compared to historical adult data.
Complete list of historical versions of study NCT00556998 on ClinicalTrials.gov Archive Site
  • AUC12 Following IV Loading Dose [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ 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.
  • Tmax Following an IV Loading Dose [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • Cmax Following an IV Loading Dose [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • Minimum Observed Plasma Trough Concentration (Cmin) [ Time Frame: Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose ] [ Designated as safety issue: No ]
  • AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion ] [ 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: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion and on Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]
  • AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: On Day 7 (up to Day 30) at 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 (up to Day 30) at 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 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
Safety and tolerability of voriconazole in adolescents
Not Provided
Not Provided
 
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
An Open-Label, Intravenous To Oral Switch, Multiple Dose Study To Evaluate The Pharmacokinetics, Safety And Tolerability Of Voriconazole In Immunocompromised Adolescents Aged 12 To <17 Years Who Are At High Risk For Systemic Fungal Infection

This study is designed to collect additional pharmacokinetic and safety data of voriconazole in immunocompromised adolescents receiving intravenous and oral voriconazole. This will help establish voriconazole dosing recommendations for adolescents.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Pharmacokinetics
Drug: Voriconazole
Voriconazole will be used for prophylaxis purpose. 6 mg/kg IV q12h on the first day (Day 1) and 4 mg/kg IV q12h for at least 5.5 days. The IV treatment is no more than 20 days. Then switch to 300 mg oral tablets q12h for at least 6.5 days. The total treatment duration is no more than 30 days.
Other Name: Vfend
Experimental: 1
Intervention: Drug: Voriconazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
26
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who are expected to develop neutropenia following chemotherapy.
  • Subjects who require treatment for the prevention of systemic fungal infection.

Exclusion Criteria:

  • Subjects with a history of severe intolerance of azole antifungal agents.
  • Subjects with documented bacterial or viral infection at the time of study entry who are not responding to appropriate treatment against the infection.
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00556998
A1501081
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP