NCT04081480

Pharmacokinetics of Valacyclovir Oral Solution in Children

Pharmacokinetics of a New Paediatric Formulation of Valacyclovir Used for Prophylaxis and Treatment of Varicella Zoster Virus (VZV) and Herpes Simplex Virus (HSV) Infections in Children, Phase II (VALID II)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

Valacyclovir has replaced acyclovir in many clinical scenarios. Pharmacokinetic data support the use of oral valacyclovir in children, but practical problems exist in children having to take adult-dose tablets. A formulation with acceptable palatability, good pharmaceutical quality and possibility of flexible dosing is developed. Pharmacokinetic data of this formulation is missing. The present study investigates the pharmacokinetics of valacyclovir oral solution in children by determine the area under the curve (AUC0-12), time above critical concentration (Ccrit), Cmax and Tmax of acyclovir. Secondary, the safety profile of a single dose of valacyclovir oral solution will be determined.

Conditions

• Herpes Simplex Virus Infection
• Varicella Zoster Virus Infection

Interventions

Type	Name	Description
DRUG	Valacyclovir	PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution

Timeline

• Start date: 2019-12-10
• Primary completion: 2021-05-12
• Completion: 2021-05-12
• First posted: 2019-09-09
• Last updated: 2021-06-10

Locations

1 site across 1 country: Netherlands