A Safety And Tolerability Study Of Valaciclovir Oral Suspension In Infants And Children

Study Overview
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Brief Summary
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Limited data are available on valaciclovir use in children and valaciclovir is not currently approved for use in pediatrics. The marketed formulation of valaciclovir is not ideal for use in pre-adolescent patients who may have trouble swallowing solid oral dosage forms. An extemporaneous suspension formulation of valaciclovir has been developed to expedite the provision of benefits to children similar to those from administration of valaciclovir solid formulations in adults.

Official Title
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An Open-label, Single-dose, Multicenter, Pharmacokinetic, Safety and Tolerability Study of Valaciclovir Oral Suspension in Infants and Children.

Conditions
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Herpes Simplex

Intervention / Treatment
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* Drug: Valaciclovir


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Subjects who have a current herpes virus infection. Have neonatally acquired herpes at risk of potential recurrence. Immunocompromised or cancer patients at risk for development of a herpes virus infection. Exclusion criteria: Hypersensitivity to antiherpetic medications. Impaired hepatic or renal function. Show presence of other serious or unstable underlying disease.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 6 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: Cohort 1<br>Subjects in the age group of 2 to less than 6 years will be included | Drug: Valaciclovir<br>* Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.<br>|
| Experimental: Cohort 2<br>Subjects in the age group of 1 to less than 2 years will be included | Drug: Valaciclovir<br>* Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.<br>|
| Experimental: Cohort 3<br>Subjects in the age group of 6 months to less than 1 year will be included | Drug: Valaciclovir<br>* Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.<br>|
| Experimental: Cohort 4<br>Subjects in the age group of 3 months to less than 6 months will be included | Drug: Valaciclovir<br>* Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.<br>|
| Experimental: Cohort 5<br>Subjects in the age group of 1 month to less than 3 months will be included | Drug: Valaciclovir<br>* Valaciclovir will be administered as an extemporaneously prepared suspension formulation. Valaciclovir oral suspension will be prepared by crushing marketed Valtrex Caplets 500 milligram (mg) and suspending the resultant powder in Suspension Structured Vehicle USNF with dose strength of 25 milligram per milliliter (mg/mL) or 50 mg/mL.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma acyclovir and valaciclovir concentrations pre-dose (within 15 minutes of dose administration) and at 0.5, 1, 2, 4 and 6 hours following administration of the valaciclovir oral suspension dose. |  | 0.5, 1, 2, 4 and 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication. |  | Up to Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus