Conditions: Herpes Simplex
Keywords: herpes simplex cold sores fever blisters children Famvir famciclovir
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 74
Healthy volunteers: no

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 description:

Arms:
arm 1: single-arm

Interventions: intervention 1: Famciclovir
Intervention descriptions: intervention 1: Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Protocol document: