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

Pfizer26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Pharmacokinetics

Interventions

VoriconazoleDRUG

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.

Eligibility

Sex: ALLMin age: 12 YearsMax age: 17 Years

Medical Language ↔ Plain English

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.

Locations (9)

Pfizer Investigational Site

Chicago, Illinois, United States

Pfizer Investigational Site

New Orleans, Louisiana, United States

Pfizer Investigational Site

Durham, North Carolina, United States

Pfizer Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion

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

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

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.

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

Cmax,ss Following Oral Administration

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

Tmax Following Oral Administration

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

Secondary Outcomes

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.

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

Data from ClinicalTrials.gov

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Cleveland, Ohio, United States

Pfizer Investigational Site

Portland, Oregon, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

Pfizer Investigational Site

Nashville, Tennessee, United States

Pfizer Investigational Site

Fort Worth, Texas, United States

Pfizer Investigational Site

Houston, Texas, United States

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

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

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

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.

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

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

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

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.

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

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

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