Phase 2
N=26
A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
Pharmacokinetics
Bottom Line
View on ClinicalTrials.gov: NCT00556998 ↗Enrolled (actual)
26
Serious AEs
16.7%
Results posted
Mar 2012
Primary outcome: Primary: Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration — 22.39 μg*h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Voriconazole (Drug)
- Age
- Pediatric · 12+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Curve Over Dosing Interval at Steady State (AUC12,ss) Following IV Administration |
22.39 | — |
| PRIMARY Peak Plasma Concentration at Steady State (Cmax,ss) Following IV Administration |
3.89 | — |
| PRIMARY Time to Reach Cmax (Tmax) Following IV Administration |
1.30 | — |
| PRIMARY AUC12,ss Following Oral Administration |
16.74 | — |
| PRIMARY Cmax,ss Following Oral Administration |
2.35 | — |
| PRIMARY Tmax Following Oral Administration |
2.00 | — |
| SECONDARY AUC12 Following IV Loading Dose |
9.14 | — |
| SECONDARY Tmax Following an IV Loading Dose |
1.97 | — |
| SECONDARY Cmax Following an IV Loading Dose |
2.25 | — |
| SECONDARY Minimum Observed Plasma Trough Concentration (Cmin) |
1.05; 0.72 | — |
| SECONDARY AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
21.18; 36.21 | — |
| SECONDARY Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
2.50; 3.48 | — |
| SECONDARY Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following IV Administration |
4.00; 4.03 | — |
| SECONDARY AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
44.07 | — |
| SECONDARY Cmax,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
4.44 | — |
| SECONDARY Tmax of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration |
5.97 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00556998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.