Clinical Trial: Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

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

Official Title: A Multicenter, Open-label, Single-arm Study to Evaluate the Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis

Brief Summary: This study will assess the safety, tolerability of a single 1500 mg dose of famciclovir in 50 adolescents with recurrent herpes labialis. Eight of the 50 adolescents will also participate in the pharmacokinetics (PK) assessment of famciclovir single 1500 mg dose

Detailed Summary: Uncontrolled study
Sponsor: Novartis Pharmaceuticals

Current Primary Outcome: Safety: Frequency of adverse events and laboratory abnormalities [ Time Frame: 48 hours, 4 days ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pharmacokinetics: Measure: AUC0-tlast (area under the penciclovir concentration-time curve from time zero to the last measurable timepoint) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ]
  • Pharmacokinetics: Measure: AUC0-∞ (area under the penciclovir concentration-time curve from time zero to infinity) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ]
  • Pharmacokinetics: Measure: Cmax (maximum observed plasma concentration of penciclovir post-dose) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ]
  • Pharmacokinetics: Measure: CL/F (apparent oral clearance of penciclovir) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ]
  • Pharmacokinetics: Measure: Tmax (time of maximum observed plasma concentration of penciclovir) [ Time Frame: Pre-dose, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 6.0, and 10.0 hours post-dose ]


Original Secondary Outcome: Same as current

Information By: Novartis

Dates:
Date Received: April 7, 2009
Date Started: March 2009
Date Completion:
Last Updated: May 1, 2012
Last Verified: May 2012