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NCT00556998 Clinical Trial

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

Pharmacokinetics Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00556998
Other study ID # A1501081
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2007
Last updated February 27, 2012
Start date June 2008
Est. completion date December 2009

Study information
Verified date February 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. AUC12,ss was obtained by the Linear/Log trapezoidal method. Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion No
Primary Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion No
Primary Time to Reach Cmax (Tmax) Following IV Administration Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion No
Primary AUC12,ss Following Oral Administration 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. Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Primary Cmax,ss Following Oral Administration Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Primary Tmax Following Oral Administration Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Secondary AUC12 Following IV Loading Dose AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method. Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Tmax Following an IV Loading Dose Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Cmax Following an IV Loading Dose Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Minimum Observed Plasma Trough Concentration (Cmin) Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration 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. 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 No
Secondary Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration 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 No
Secondary Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration 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 No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration 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. On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Secondary Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Secondary Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
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