Clinical trial NCT00556998: A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pharmacokinetics
Keywords: pharmacokinetics and safety data of voriconazole in immunocompromised adolescents
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-12
Enrollment: 26
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration
timeFrame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration
timeFrame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: Time to Reach Cmax (Tmax) Following IV Administration
timeFrame: Day 7 (up to Day 20) at predose, 40, 78 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: AUC12,ss Following Oral Administration
timeFrame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
measure: Cmax,ss Following Oral Administration
timeFrame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
measure: Tmax Following Oral Administration
timeFrame: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose
Secondary outcomes:
measure: AUC12 Following IV Loading Dose
timeFrame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: Tmax Following an IV Loading Dose
timeFrame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: Cmax Following an IV Loading Dose
timeFrame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
measure: Minimum Observed Plasma Trough Concentration (Cmin)
timeFrame: Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose
measure: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: 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
measure: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: 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
measure: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration
timeFrame: 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
measure: AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
measure: Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
measure: Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration
timeFrame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose
Other outcomes:
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.
timeFrame: Day 1
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State
timeFrame: Day 7 of IV dosing
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects
timeFrame: Day 7 Oral dosing
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral 300mg
timeFrame: Day 7 oral dosing
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Loading Dose
timeFrame: Day 1
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax IV Steady State
timeFrame: Day 7 of Intravenous dosing
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax Day 7 Oral All Participants
timeFrame: Day 7 of oral dosing
measure: Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - Cmax 300 mg Oral Dose
timeFrame: Day 7 of oral dosing
Locations:
city: Chicago
country: United States
facility: Pfizer Investigational Site
state: Illinois
city: New Orleans
country: United States
facility: Pfizer Investigational Site
state: Louisiana
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Portland
country: United States
facility: Pfizer Investigational Site
state: Oregon
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
city: Fort Worth
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: