Physiologically Based Pharmacokinetic Modeling of Elexacaftor/Tezacaftor/Ivacaftor in Infants With Cystic Fibrosis - PubMed
3 hours ago
- #PBPK modeling
- #Cystic fibrosis
- #Pharmacokinetics
- The study uses physiologically based pharmacokinetic (PBPK) modeling to predict the pharmacokinetics of elexacaftor/tezacaftor/ivacaftor in infants aged 1 month to under 2 years with cystic fibrosis.
- Simulations suggest that doses extrapolated from ivacaftor monotherapy generally match adult drug exposures in infants, except for lower exposures in those aged 1-2 months and potentially higher exposures in infants weighing ≥ 14 kg.
- The findings provide preliminary dosing guidance for infants under 2 years, pending larger clinical studies, and recommend therapeutic drug monitoring to optimize treatment.