drugset / Trial / NCT05468619
Neonatal Phase 1 Valacyclovir Study
Non-randomizedSingle-groupOpen-labelPrevention
Summary
A Phase 1 study that will determine the valacyclovir dose that results in a systemic acyclovir exposure comparable to 10 mg/kg of parenterally administered acyclovir, which is an AUC0-12 of 24,000 ngxhr/mL to 48,000 ngxhr/mL. Neonates at risk of acquiring neonatal HSV will be enrolled in one of 2 cohorts. Cohort 1 will be comprised of eight subjects who will receive an initial dose of 10ml/kg of oral valacyclovir. Samples for PK assessments will be obtained to assess the exposure concentration. If the safety profile and the drug exposure concentrations in Cohort 1 are acceptable, eight new subjects will be enrolled in Cohort 2. The dose that these subjects will receive will be predicated upon the pharmacokinetic data from Cohort 1.
Timeline
- Start
- 2023-08-07
- Primary completion
- 2025-06-08
- Completion
- 2025-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Valacyclovir | Unknown | 10 mg/kg | Oral |
| Subject | Valacyclovir | Unknown | 20 mg/kg | Oral |