A Multiple-Dose Study To Evaluate The Pharmacokinetics And Safety Of Voriconazole In Immunocompromised Adolescents
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00556998
First received: November 9, 2007
Last updated: February 27, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pharmacokinetics |
Drug: Voriconazole |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Area Under the Curve Over Dosing Interval at Steady State (AUC12,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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- AUC12,ss Following Oral Administration [ Time Frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]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 [ Time Frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
- Tmax Following Oral Administration [ Time Frame: Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- AUC12 Following IV Loading Dose [ Time Frame: Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion ] [ Designated as safety issue: No ]AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method.
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- AUC12,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 ] [ Designated as safety issue: No ]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 [ 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) Following Oral Administration [ Time Frame: On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]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 Oral Administration [ Time Frame: Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 26 |
| Study Start Date: | June 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
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.
Other Name: Vfend
|
Eligibility| Ages Eligible for Study: | 12 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00556998
Locations
| United States, Illinois | |
| Pfizer Investigational Site | |
| Chicago, Illinois, United States, 60637 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| New Orleans, Louisiana, United States, 70118 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27705 | |
| United States, Ohio | |
| Pfizer Investigational Site | |
| Cleveland, Ohio, United States, 44106 | |
| United States, Oregon | |
| Pfizer Investigational Site | |
| Portland, Oregon, United States, 97239 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232 | |
| Pfizer Investigational Site | |
| Nashville, Tennessee, United States, 37232-2195 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| Fort Worth, Texas, United States, 76104-2796 | |
| Pfizer Investigational Site | |
| Houston, Texas, United States, 77030 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00556998 History of Changes |
| Other Study ID Numbers: | A1501081 |
| Study First Received: | November 9, 2007 |
| Results First Received: | August 2, 2010 |
| Last Updated: | February 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
pharmacokinetics and safety data of voriconazole in immunocompromised adolescents |
Additional relevant MeSH terms:
|
Voriconazole Antifungal Agents Anti-Infective Agents Therapeutic Uses |
Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013