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

GlaxoSmithKline36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Herpes Simplex

Interventions

ValaciclovirDRUG

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.

Eligibility

Sex: ALLMin age: 1 MonthMax age: 6 Years

Medical Language ↔ Plain English

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.

Locations (13)

GSK Investigational Site

Birmingham, Alabama, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

San Diego, California, United States

Outcomes

Primary Outcomes

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.

Time frame: 0.5, 1, 2, 4 and 6 hours

Secondary Outcomes

Safety monitoring throughout the study and at the follow up evaluation 2-4 days after the single dose of study medication.

Time frame: Up to Day 5

Data from ClinicalTrials.gov

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