Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Uncontrolled study
Age
12–18
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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 Class C)
Significant skin disease such as atopic dermatitis or eczema that would interfere with assessment of oral/labial lesions
Known to be immunocompromised or are receiving systemic or using topical immunosuppressive agents (including corticosteroids, tacrolimus and picrolimus) within 30 days of enrollment
Concomitant use of probenecid
Pregnant or nursing (lactating) females
Females of child-bearing potential, UNLESS they are using two birth control methods. The two methods can be a double barrier method or a barrier method plus a hormonal method.
Clareo Health | Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
