Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

• Pharmacokinetics of Single Dose - Tmax [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
  Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached.
• Pharmacokinetics of Single Dose - Cmax [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
  Measured by Cmax - The maximum plasma concentration of study medication
• Pharmacokinetics of Single Dose - AUC(0-tlast) [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
  Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint.
• Pharmacokinetics of Single Dose - AUC(0-6h) [ Time Frame: Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. ] [ Designated as safety issue: No ]
  Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample).

• Safety Assessed by AEs, SAEs [ Time Frame: 38 days ] [ Designated as safety issue: No ]
  AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose.
• Safety Assessed by Labs [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory.
• Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. [ Time Frame: 30 minutes after dosing ] [ Designated as safety issue: No ]

  Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale:

  1. Significant emesis occurred,
  2. Infant spit out most of the dose ingesting less than half of what was administered,
  3. Infant spit out some of the dose, but ingested at least 50% of what was administered,
  4. Infant was able to ingest and retain the dose administered
• Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]

  Assessed by the caregiver using a 5-point scale immediately after dosing:

  1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
  2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
  3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
  4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
  5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing
• Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel [ Time Frame: Immediately after dosing ] [ Designated as safety issue: No ]

  Assessed by the study personnel using a 5-point scale after dosing:

  1. Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation
  2. Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose
  3. Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose
  4. Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose
  5. Very well accepted: infant appeared eager and ingested most of dose without special coaxing

• Safety assessed by AEs, SAEs and Labs
• Tolerability and acceptability assessed by questionnaire

This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Inclusion Criteria:

• Male and female patients from 1 month up to 1 year of age with herpes simplex infection

Exclusion Criteria:

• Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery.

Other protocol-defined inclusion/exclusion criteria may apply.