Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection

Study Overview
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Brief Summary
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This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection

Official Title
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A Multicenter, Open-label, Single-arm Study to Evaluate the Single-dose Pharmacokinetics, Acceptability and Safety of Famciclovir Oral Pediatric Formulation in Infants 1 Month to Less Than 1 Year of Age With Herpes Simplex Virus Infections

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: Male and female patients from 1 month up to 1 year of age with herpes simplex infection Exclusion Criteria: Patients with gestational age less than 32 weeks. Patients unable to swallow. Patients with history of malabsorption or previous gastrointestinal surgery. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 1 Year

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<br>Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight. | Drug: famciclovir<br>* Administered orally as a single individualized dose between 25-200 mg based on body weight.<br>* Other names: Famvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of Single Dose - Tmax | Measured by Tmax - The time after administration of a drug when the maximum plasma concentration is reached. | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. | 
| Pharmacokinetics of Single Dose - Cmax | Measured by Cmax - The maximum plasma concentration of study medication | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. | 
| Pharmacokinetics of Single Dose - AUC(0-tlast) | Measured by AUC(0-tlast) - Area under the plasma concentration time curve from time zero to the last quantifiable concentration-timepoint. | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. | 
| Pharmacokinetics of Single Dose - AUC(0-6h) | Measured by AUC(0-6h) - Area under the plasma concentration time curve from time zero up to 6 hours post dose (i.e. the time of the last sample). | Plasma samples were collected at 0.5, 1, 4 and 6 hours after dosing. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessed by AEs, SAEs | AEs and SAEs were collected during patient's stay in the clinic for PK sampling up to Hour 8, then at day 2 visit, 8 days(safety follow-up call) and 38 days (safety follow-up call) post dose. | 38 days | 
| Safety Assessed by Labs | Samples for safety labs were obtained at baseline and Day 2 visit and samples were analyzed by local accredited laboratory. | 2 days | 
| Tolerability of of the Famciclovir Pediatric Formulation as Assessed by Study Personnel. | Tolerability was assessed by the study personnel 30 minutes after dosing using the following scale: Significant emesis occurred, Infant spit out most of the dose ingesting less than half of what was administered, Infant spit out some of the dose, but ingested at least 50% of what was administered, Infant was able to ingest and retain the dose administered | 30 minutes after dosing | 
| Acceptability of the Famciclovir Pediatric Formulation as Assessed by the Patient's Caregiver | Assessed by the caregiver using a 5-point scale immediately after dosing: Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose Very well accepted: infant appeared eager and ingested most of dose without special coaxing | Immediately after dosing | 
| Acceptability of the Famciclovir Pediatric Formulation as Assessed by Study Personnel | Assessed by the study personnel using a 5-point scale after dosing: Very badly accepted/unacceptable: infant showed great displeasure, compromising use of formulation Badly but accepted: infant showed displeasure with dosing but could be coaxed to take complete dose Neither good nor bad: infant showed no apparent displeasure and with little effort was coaxed to take complete dose Well accepted: infant appeared to enjoy the formulation and with little coaxing ingested most of dose Very well accepted: infant appeared eager and ingested most of dose without special coaxing | Immediately after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infants, Herpes simplex infection