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

• 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) ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  PK parameter; penciclovir is the active metabolite of famciclovir
• Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. [ Time Frame: Administered 2 times daily over 7 days ] [ Designated as safety issue: No ]
  A patient with multiple AEs within the primary system organ class is counted only once in total row.

• Safety
• Blood levels

• Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. [ Time Frame: Day 1, after swallowing the dose. ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Overall acceptability of study medication was determined by caretaker response.

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.

Inclusion Criteria:

• History or laboratory evidence of herpes simplex infection
• Clinical evidence or suspicion of herpes simplex infection

Exclusion Criteria:

• Patients unable to swallow
• Concomitant use of probenecid
• Positive pregnancy test

Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228