Status:
COMPLETED
Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Herpes Labialis
Eligibility:
All Genders
12-18 years
Phase:
PHASE2
PHASE3
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 pharm...
Detailed Description
Uncontrolled study
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 2 2010
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00878072
Start Date
March 25 2009
End Date
June 2 2010
Last Update
June 25 2021
Active Locations (12)
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1
Women's Health Care at Frost Street
San Diego, California, United States
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
Medisphere Medical Research Center, LLC
Evansville, Indiana, United States, 47714
4
Clayton Medical Research
St Louis, Missouri, United States, 63117