Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herp… (NCT00878072) | Clinical Trial Compass
CompletedPhase 2/3
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
United States53 participantsStarted 2009-03-25
Plain-language 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
Who can participate
Age range12 Years – 18 Years
SexALL
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Inclusion Criteria:
* Outpatient males or females 12 to \<18 years of age
* General good health with a documented history typical for recurrent herpes labialis
* Prodromal symptoms or active lesions suggestive of a recurrent episode of herpes labialis (i.e. having had cold sores in the past) , with onset not exceeding 24 hours until the time of study drug administration
* Adolescents participating in Pharmacokinetics (PK) part of the study may be enrolled without an active herpes labialis recurrence or with onset of signs/symptoms of a recurrent herpes labialis episode longer than 24 hours before study drug administration, All adolescents participating in the pharmacokinetics assessments must fast for at least 8 hours prior to Visit 1 and be willing to fast for an additional 2 hours after study drug administration
Exclusion Criteria:
* Use of other investigational drugs within 30 days of enrollment
* History of hypersensitivity to famciclovir or penciclovir
* Inability to swallow tablets
* Body weight less than 40 Killograms (kg)
* History of malabsorption, unless a condition like celiac disease is stable and well controlled, previous gastrointestinal surgery or radiation therapy that could affect drug absorption or metabolism, or any condition that could interfere with drug absorption, distribution, metabolism, or excretion
* Known renal insufficiency (calculated creatinine clearance \<60 \[Milliliters/Minutes\] mL/min)
* Known severe hepatic impairment (Child-Pugh Cla…
What they're measuring
1
Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)
Timeframe: From Start of the Study up to Day 36
2
Number of Participants With Clinically Significant Laboratory Abnormalities