Clinical Trials Logo
  1. Home
  2. Pharmacokinetics
  3. NCT00556998
  4. Details
NCT00556998 Clinical Trial

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

Pharmacokinetics Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00556998
Other study ID # A1501081
Secondary ID
Status Completed
Phase Phase 2
First received November 9, 2007
Last updated February 27, 2012
Start date June 2008
Est. completion date December 2009

Study information
Verified date February 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 26
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 17 Years
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Pfizer Investigational Site Chicago Illinois
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fort Worth Texas
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site Nashville Tennessee
United States Pfizer Investigational Site New Orleans Louisiana
United States Pfizer Investigational Site Portland Oregon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Primary 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 No
Primary Cmax,ss Following Oral Administration Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Primary Tmax Following Oral Administration Day 7 (up to Day 30) Predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Secondary AUC12 Following IV Loading Dose AUC12 = Area under the plasma concentration-time profile from time zero (predose) to twelve hours. AUC12 was obtained by the Linear/Log trapezoidal method. Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Tmax Following an IV Loading Dose Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Cmax Following an IV Loading Dose Day 1 at predose, 60, 118 minutes, 4, 6, 8 and 12 hours after start of infusion No
Secondary Minimum Observed Plasma Trough Concentration (Cmin) Day 7 (up to Day 20) for IV; Day 7 (up to Day 30) for oral at predose No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) 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 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 No
Secondary 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 No
Secondary 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 No
Secondary AUC12,ss of N-oxide Voriconazole Metabolite (UK-121, 265) 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. On Day 7 (up to Day 30) at predose, 1, 2, 4, 6, 8, and 12 hours postdose No
Secondary 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 No
Secondary 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 No
See also
  Status Clinical Trial Phase
Completed NCT04092725 - Study to Evaluate the Effect of SCY-078 on the PK of Dabigatran in Healthy Subjects Phase 1
Completed NCT04181008 - Pharmacokinetics of Amiloride Nasal Spray in Healthy Volunteers Early Phase 1
Active, not recruiting NCT03258151 - Association of Genetic Polymorphisms With Docetaxel-based Chemotherapy Toxicities in Chinese Solid Tumor Patients
Completed NCT04406415 - Oral Nafamostat in Healthy Volunteers Phase 1
Not yet recruiting NCT05421312 - Periarticular Penetration of Cefazolin and Clindamycin in Second Stage Revision Arthroplasty of the Hip Phase 4
Completed NCT02534753 - A Pharmacokinetics Study of Intravenous Ascorbic Acid Phase 1
Completed NCT01682408 - Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability Phase 1
Completed NCT01636024 - To Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending Doses of Inhaled AZD7594 Phase 1
Completed NCT01976078 - Development of Voriconazole Pharmacokinetics and Metabolism in Children and Adolescents N/A
Completed NCT01208155 - Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets Phase 1
Completed NCT01415102 - A First In Human Study In Healthy People To Evaluate Safety, Toleration And Time Course Of Plasma Concentration Of Single Inhaled Doses Of PF-05212372. Phase 1
Completed NCT01214941 - Effect of Itraconazole and Ticlopidine on the Pharmacokinetics and Pharmacodynamics of Oral Tramadol Phase 4
Completed NCT01260025 - Tolerability and Pharmacokinetics of M2ES in the Treatment of Advanced Solid Tumor Phase 1
Completed NCT00746499 - Pharmacokinetic Study of Raltegravir in Healthy Premenopausal Women. Phase 1
Completed NCT00856570 - A Clinical Study to Determine the Effect of YM178 on the Pharmacokinetics of Warfarin in Healthy Subjects Phase 1
Completed NCT01055964 - a Comparative Pharmacokinetic Study of Two Oral Formulations of Tacrolimus in Renal Allograft Recipients Phase 3
Completed NCT00730145 - A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis Phase 1
Completed NCT00747721 - Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU Phase 1
Completed NCT00984009 - A Drug-Food Interaction Study Between Colchicine and Grapefruit Juice Phase 1
Completed NCT00983242 - Drug-Drug Interaction Between Colchicine and Verapamil ER Phase 1

External Links