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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00297206

Enrollment

Registered

2006-02-28

Start date

2003-01-25

Completion date

2007-02-28

Last updated

2017-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Herpes Simplex

Keywords

pharmacokinetics herpes varicella herpes labialis Epstein-Barr virus

Brief summary

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.

Interventions

DRUGValaciclovir

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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 6 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

Chile, South Africa, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026