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

Phase 2

Completed

• Conditions: Pharmacokinetics
• Interventions: Drug: Voriconazole

• Registration Number: NCT00556998
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-11-09
• Study First Submitted QC: 2007-11-09
• Study First Posted: 2007-11-12
• Study Start: 2008-06
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2010-08-02
• Results First Submitted QC: 2012-02-27
• Results First Posted: 2012-03-16
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Voriconazole	-

Primary Outcome Measures

Name	Time	Method
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
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
Area Under the Curve Over Dosing Interval at Steady State (AUC12,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	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.
Tmax Following Oral Administration	Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose
AUC12,ss Following Oral Administration	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.
Cmax,ss Following Oral Administration	Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose

Secondary Outcome Measures

Name	Time	Method
AUC12 Following IV Loading Dose	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.
Cmax Following an IV Loading Dose	Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Tmax Following an IV Loading Dose	Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion
Minimum Observed Plasma Trough Concentration (Cmin)	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	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.
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
AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration	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.
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
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
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Houston, Texas, United States