Clinical trial NCT00878072: Safety and Pharmacokinetics of Famciclovir Single 1500 mg Dose in Adolescents With Recurrent Herpes Labialis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Herpes Labialis
Keywords: Herpes labialis
cold sores
herpes simplex type 1
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-04-08
Enrollment: 53
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 description: Uncontrolled study

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)
timeFrame: From Start of the Study up to Day 36
measure: Number of Participants With Clinically Significant Laboratory Abnormalities
timeFrame: From Start of the Study up to Day 36
Secondary outcomes:
measure: Time of Maximum Observed Plasma Concentration (Tmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
measure: Maximum Plasma Concentration (Cmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
measure: Area Under the Plasma Concentration of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
measure: Area Under the Plasma Concentration-Time Curve From Time 0 to Infinity (AUC 0-infinity) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
measure: Apparent Terminal Elimination Half-Life (T½) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
measure: Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir)
timeFrame: Pre-dose and at 0.5, 1, 1.5, 2, 3, 4, 6 and 10 hours Post-dose
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Women's Health Care at Frost Street
state: California
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
city: Evansville
country: United States
facility: Medisphere Medical Research Center, LLC
state: Indiana
city: Saint Louis
country: United States
facility: Clayton Medical Research
state: Missouri
city: Rochester
country: United States
facility: Rochester Clinical Research, Inc.
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Portland
country: United States
facility: Westover Heights Clinic
state: Oregon
city: Pittsburgh
country: United States
facility: Primary Physicians Research, Inc
state: Pennsylvania
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research
state: Texas
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Block SL, Yogev R, Waldmeier F, Hamed K. Safety and pharmacokinetics of a single 1500-mg dose of famciclovir in adolescents with recurrent herpes labialis. Pediatr Infect Dis J. 2011 Jun;30(6):525-8. doi: 10.1097/INF.0b013e3182067cee.