Famciclovir Pediatric Formulation in Children 1 to 12 Years of Age With Herpes Simplex Infection

Study Overview
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Brief Summary
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This study will evaluate the safety and blood levels of a new pediatric formulation of Famvir in children 1-12 years of age. In Part A, patients will receive a single dose of famciclovir (12.5 mg/kg) to assess pharmacokinetics (PK) and safety. In Part B, patients will receive multiple doses of famciclovir alone or with concomitant oral anti-herpes therapy to assess safety and tolerability. Part B will start only after PK data from Part A had been analyzed.

Official Title
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A Multicenter, Open-label, Single-arm, Two-step Study to Evaluate the Safety and Single-dose Pharmacokinetics of Famciclovir and Multiple-dose Safety After Administration of Famciclovir Oral Pediatric Formulation to Children 1 to 12 Years of Age With Herpes Simplex Infection

Conditions
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Herpes Simplex

Intervention / Treatment
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* Drug: Famciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History or laboratory evidence of herpes simplex infection Clinical evidence or suspicion of herpes simplex infection Exclusion Criteria: Patients unable to swallow Concomitant use of probenecid Positive pregnancy test Additional protocol-defined inclusion/exclusion criteria may apply. For detailed information on eligibility, please contact the study center nearest to you or call the following numbers: 1-862-778-3544 or 1-434-951-3228

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Famciclovir, pediatric oral formulation<br>single-arm | Drug: Famciclovir<br>* Famciclovir sprinkle capsules, 25 mg and 100 mg, using OraSweet® syrup vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of a Single-dose of Famciclovir in Part A of the Study. | A patient with multiple adverse events (AEs) within the primary system organ class is counted only once in total row. | 8 hours and 24 hours after study drug administration (Part A) | 
| Maximum Observed Plasma Concentration of Penciclovir (Cmax) | PK parameter; penciclovir is the active metabolite of famciclovir. | plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | 
| Time of Maximum Observed Plasma Concentration of Penciclovir (Tmax) | PK parameter; penciclovir is the active metabolite of famciclovir. | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | 
| Area Under the Penciclovir Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | PK parameter; penciclovir is the active metabolite of famciclovir. | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | 
| Apparent Oral Clearance of Penciclovir (CL/F) | PK parameter; penciclovir is the active metabolite of famciclovir. | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | 
| Apparent Terminal Elimination Half-life of Penciclovir (T1/2) | PK parameter; penciclovir is the active metabolite of famciclovir | Plasma level measurements: pre-dose, 1, 2, 3, 4 and 5 hours post-dose | 
| Safety and Tolerability of Famciclovir Pediatric Oral Formulation in Part B of the Study. | A patient with multiple AEs within the primary system organ class is counted only once in total row. | Administered 2 times daily over 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part A of the Study. | Overall acceptability of the study medication was determined by caretaker response. | Day 1, after swallowing the dose. | 
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study. | Overall acceptability of the study medication was determined by caretaker response. | Day 1 at clinic: after swallowing first dose | 
| Overall Acceptability of Pediatric Oral Formulation by Patients in Part B of the Study | Overall acceptability of study medication was determined by caretaker response. | Day 8 at home: after swallowing last dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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famciclovir, herpes simplex, cold sores, fever blisters, children, Famvir