This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle
University of Alabama at Birmingham
Birmingham, Alabama, United States
The Children's Hospital
Denver, Colorado, United States
Children's Memorial Hospital
Chicago, Illinois, United States
Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study.
A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
Time frame: 8 hours and 24 hours after study drug administration (Part A)
Maximum Observed Plasma Concentration of Penciclovir (Cmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Apparent Oral Clearance of Penciclovir (CL/F)
PK parameter; penciclovir is the active metabolite of famciclovir.
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Apparent Terminal Elimination Half-life of Penciclovir (T1/2)
PK parameter; penciclovir is the active metabolite of famciclovir
Time frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose
Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study.
A patient with multiple AEs within the primary system organ class is counted only once in total row.
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Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
Columbia University Medical Center
New York, New York, United States
State University of New York at
Stony Brook, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland
Cleveland, Ohio, United States
Children's Medical Center of Dallas
Dallas, Texas, United States
...and 3 more locations
Time frame: Administered 2 times daily over 7 days
Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Time frame: Day 1, after swallowing the dose.
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study.
Overall acceptability of the study medication was determined by caretaker response.
Time frame: Day 1 at clinic: after swallowing first dose
Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study
Overall acceptability of study medication was determined by caretaker response.
Time frame: Day 8 at home: after swallowing last dose