Predicting Maternal and Fetal Exposures of Elexacaftor-Tezacaftor-Ivacaftor during Pregnancy through Physiologically Based Pharmacokinetic Models.

ABSTRACT: The use of elexacaftor/tezacaftor/ivacaftor (ETI) has been associated with increased fertility in women with cystic fibrosis (CF) and is increasingly used during pregnancy to support both maternal and fetal health. However, little is known about the pharmacokinetics (PK) of ETI during pregnancy, which is crucial for optimizing its efficacy and safety. This study aimed to predict the PK of ETI during pregnancy and to determine the maternal dose required to achieve therapeutic concentrations in both the maternal and fetus. The pregnancy physiological-based pharmacokinetic (PBPK) model within the Simcyp Simulator was used to predict the maternal and feto-placental exposure of ETI. Placental kinetics were parameterized using permeability parameters determined from the physicochemical propertie

SUBMITTER: Hong E 

PROVIDER: S-EPMC12353614 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature