Systemic Fungal Infection MedDRA version: 18.0 Level: LLT Classification code 10042941 Term: Systemic fungal infection NOS System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Vfend
Product Name: Vfend
Product Code: UK-109496
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: VORICONAZOLE
CAS Number: 137234-62-9
Current Sponsor
Sponsors
Pfizer, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children (both male and female) aged from 2 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects who were receiving and could not discontinue the following drugs at least 24 hours prior to study start: Terfenadine and cisapride (due to the possibility of QTc prolongation with these drugs) Omeprazole (an inhibitor of CYP2C19) which is known to increase plasma voriconazole levels. Subjects who had received the following drugs within 14 days prior to study entry: Rifampicin, rifabutin, carbamazepine, phenytoin, nevirapine and barbiturates as these are inducers of hepatic enzymes and may result in undetectable levels of voriconazole. 2. Subjects who had received astemizole within the previous 60 days. 3. Subjects with any clinically significant abnormality following review of screening laboratory data other than that associated with their underlying disease. Aspartate transaminase (AST) and alanine transaminase (ALT) had to be <5 * upper limit of normal. 4. Subjects who were taking or were likely to receive any investigational drug except: those used for the treatment of child’s cancer, antiretroviral agents and drugs used for treatment of any acquired immune deficiency syndrome (AIDS) defining opportunistic infections, all of which were allowed. 5. Subjects with a history of hypersensitivity to or severe intolerance of azole antifungal agents. 6. Subjects who had already been entered into this protocol once. 7. Subjects with moderate and severe renal impairment ( i.e. calculated creatinine clearance <30 millilitre per minute (ml/min). If creatinine clearance was reduced to <30 ml/min at any time during the study, the subject had to be discontinued from the study. Creatinine clearance was calculated using the equation Creatinine Clearance (ml/min) = 0.55*height (cm)/serum creatinine (mg/dL) 8. Subjects with a medical history or current evidence of cardiac arrhythmia. 9 Any other condition which, in the opinion of the investigator, would make the subject unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the pharmacokinetics of voriconazole following multiple dosing with intravenous voriconazole in children aged 2 to less than (<)12 years. ;Secondary Objective: To evaluate the safety and toleration of multiple dose administration of voriconazole in children requiring treatment for the prevention of systemic fungal infection; and to evaluate the plasma concentrations of the major metabolite of voriconazole (N-oxide) in these subjects.;Primary end point(s): 1. Plasma Concentration of Voriconazole on Day 4. 2. Plasma Concentration of Voriconazole on Day 8.;Timepoint(s) of evaluation of this end point: 1. Pre-dose and end of infusion on Day 4. 2. Pre-dose and end of infusion on Day 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of Subjects with Treatment Emergent Adverse Event and Serious Adverse Event. 2. Plasma Concentration of Voriconazole (N-oxide) on Day 4 and Day 8.;Timepoint(s) of evaluation of this end point: 1. Up to Day 21. 2. Pre-dose and end of infusion on Day 4 and Day 8. | — |
Countries
Panama, United States
Contacts
Public ContactClinicalTrials.gov Call Center
Pfizer, Inc.
Outcome results
None listed