Phase 3 N=53 Treatment

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

Herpes Labialis

Bottom Line

View on ClinicalTrials.gov: NCT00878072 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs) — 6; 6; 0; 0 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Famciclovir (Drug)
Age: Pediatric, Adult · 12+ yrs
Sex: All
Sponsor: Novartis Pharmaceuticals
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Reported Adverse Events (AEs), Serious Adverse Events (SAEs)	6; 6; 0; 0	—
PRIMARY Number of Participants With Clinically Significant Laboratory Abnormalities	0; 0; 0; 0; 0; 0	—
SECONDARY Time of Maximum Observed Plasma Concentration (Tmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)	1; 1	—
SECONDARY Maximum Plasma Concentration (Cmax) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)	9.37; 3.32	—
SECONDARY Area Under the Plasma Concentration of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)	30.80; 5.42	—
SECONDARY 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)	31.76; 6.61	—
SECONDARY Apparent Terminal Elimination Half-Life (T½) of Penciclovir (Active Metabolite From Famciclovir) and 6-deoxypenciclovir (First Intermediate Metabolite From Famciclovir)	1.81; 0.78	—
SECONDARY Apparent Oral Clearance of Penciclovir From Plasma (CL/F) of Penciclovir (Active Metabolite From Famciclovir)	38.2	—

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

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.

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Data sourced from ClinicalTrials.gov (NCT00878072). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.