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

Novartis

Status and phase

Completed

Phase 3

Phase 2

Conditions

Herpes Labialis

Treatments

Drug: Famciclovir

Study type

Interventional

Funder types

Industry

Identifiers

NCT00878072

CFAM810B2305

Details and patient eligibility

About

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

Full description

Uncontrolled study

Enrollment

53 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

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 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.