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.

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.

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.

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.

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

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.

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Bradley J, Scholtz F, Brennan C, Zhao H, Weller S. Pharmacokinetics and safety of single-dose valacyclovir oral suspension in infants and children with current or potential herpesvirus infection. Poster presentation, 45th Annual Meeting Infectious Disease

Kimberlin DW, Jacobs RF, Weller S, van der Walt JS, Heitman CK, Man CY, Bradley JS. Pharmacokinetics and safety of extemporaneously compounded valacyclovir oral suspension in pediatric patients from 1 month through 11 years of age. Clin Infect Dis. 2010 Jan 15;50(2):221-8. doi: 10.1086/649212.

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.