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OpenTrials
Completed

NCT Number: NCT00556998

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

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.

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Key information

Conditions

Pharmacokinetics

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Pfizer Investigational Site, Chicago, Illinois, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voriconazole

Drug

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 names: Vfend

Primary outcomes

  1. 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

    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.

  2. 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

  3. 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

  4. AUC12,ss Following Oral Administration

    Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

    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.

  5. Cmax,ss Following Oral Administration

    Time frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

  6. Tmax Following Oral Administration

    Time frame: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose

Secondary outcomes

  1. AUC12 Following IV Loading Dose

    Time frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion

    AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.

  2. 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

  3. 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

  4. 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

  5. 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

    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.

  6. 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

  7. 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

  8. 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

    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.

  9. 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

  10. 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

Other outcomes

  1. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.

    Time frame: Day 1

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  2. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State

    Time frame: Day 7 of IV dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  3. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects

    Time frame: Day 7 Oral dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  4. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg

    Time frame: Day 7 oral dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  5. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose

    Time frame: Day 1

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  6. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State

    Time frame: Day 7 of Intravenous dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  7. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants

    Time frame: Day 7 of oral dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

  8. Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose

    Time frame: Day 7 of oral dosing

    Data for this Outcome Measure are not reported here because the analysis population includes participants who were not enrolled in this study. ClinicalTrials.gov is designed for reporting results from only those participants who were enrolled in the study and described in the Participant Flow and Baseline Characteristics modules.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 12, 2007
Registry last updated
May 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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