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

NCT00556998 | Completed Phase 2 Results

• 1 other identifier: A1501081
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 9

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.

Conditions

Pharmacokinetics

Keywords

pharmacokinetics and safety data of voriconazole in immunocompromised adolescents

Outcome Measures

Primary Outcomes (6)

• 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.

  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

  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

• 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.

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

• Cmax,ss Following Oral Administration

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

• Tmax Following Oral Administration

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

Secondary Outcomes (10)

• AUC12 Following 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

• Cmax 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

Other Outcomes (8)

• Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Loading Dose.

  Day 1

• Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 IV Steady State

  Day 7 of IV dosing

• Pharmacokinetic Parameters of Voriconazole in Adolescents Compared to Historical Adult Data - AUC12 Oral Dose All Subjects

  Day 7 Oral dosing

Study Arms (1)

1

EXPERIMENTAL

Drug: Voriconazole

Interventions

Voriconazole DRUG

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.

Also known as: Vfend

1

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subjects who are expected to develop neutropenia following chemotherapy.
• Subjects who require treatment for the prevention of systemic fungal infection.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Chicago, Illinois, 60637, United States

Location

Pfizer Investigational Site

New Orleans, Louisiana, 70118, United States

Location

Pfizer Investigational Site

Durham, North Carolina, 27705, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44106, United States

Location

Pfizer Investigational Site

Portland, Oregon, 97239, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232-2195, United States

Location

Pfizer Investigational Site

Nashville, Tennessee, 37232, United States

Location

Pfizer Investigational Site

Fort Worth, Texas, 76104-2796, United States

Location

Pfizer Investigational Site

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Voriconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2007
• First Posted: November 12, 2007
• Study Start: June 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 5, 2016
• Results First Posted: March 16, 2012

Record last verified: 2016-03

Locations

US (9)