Clinical Trial: Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric

Brief Summary: 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.

Detailed Summary:
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome:

  • Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. [ Time Frame: 8 hours and 24 hours after study drug administration (Part A) ]
    A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row.
  • Maximum Observed Plasma Concentration of Penciclovir (Cmax) [ Time Frame: plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.
  • Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.
  • Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.
  • Apparent Oral Clearance of Penciclovir (CL/F) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the active metabolite of famciclovir.
  • Apparent Terminal Elimination Half-life of Penciclovir (T1/2) [ Time Frame: Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose ]
    PK parameter; penciclovir is the a

    Original Primary Outcome:

    • Safety
    • Blood levels


    Current Secondary Outcome:

    • Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Day 1, after swallowing the dose. ]
      Overall acceptability of the study medication was determined by caretaker response.
    • Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. [ Time Frame: Day 1 at clinic: after swallowing first dose ]
      Overall acceptability of the study medication was determined by caretaker response.
    • Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study [ Time Frame: Day 8 at home: after swallowing last dose ]
      Overall acceptability of study medication was determined by caretaker response.


    Original Secondary Outcome:

    Information By: Novartis

    Dates:
    Date Received: December 2, 2004
    Date Started: February 2005
    Date Completion:
    Last Updated: April 18, 2013
    Last Verified: April 2013