NCT00098059

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 1 Year – 12 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Herpes Simplex

Interventions

Type	Name	Description
DRUG	Famciclovir	Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle

Timeline

• Start date: 2005-02-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2004-12-03
• Last updated: 2013-04-25
• Results posted: 2009-05-06

Locations

13 sites across 2 countries: United States, Panama