Letermovir PK Study

CPIC 8603: A Phase I, Adaptive, Escalating Single-Dose and Multiple-Dose Pharmacokinetic and Safety Assessment of Letermovir in Infants with Symptomatic Congenital Cytomegalovirus Disease

Status: Not Yet Recruiting

Congenital cytomegalovirus (CMV) infection is common and the leading viral cause of sensorineural hearing loss (SNHL) and mental retardation in infants. Despite current treatment options, babies with symptomatic congenital CMV disease are still at risk for hearing loss and neurologic deficits. Letermovir is the first new antiviral treatment of CMV to be licensed in over two decades. The purpose of this study is to characterize the blood concentration, dose-response, clearance, and safety profile of letermovir in newborns and young infants with symptomatic congenital CMV disease. The study will use four different dosing groups; three groups will have single doses of increasing concentrations of letermovir, and the fourth group will have multiple doses of the best single dose concentration. The multiple-dose group will receive letermovir both in month 1 and month 3 of life to track changes in dose-response over time. The goal of this study is to improve treatment options for symptomatic congenital CMV disease.