Publication: Frontiers in Pharmacology
Abstract
ORIN1001 is a first-in-class oral IRE1-alpha endoribonuclease inhibitor in early clinical development for solid tumors, and characterizing its population pharmacokinetics could help guide future dose selection. This study used data from a Phase I trial in Chinese patients with advanced solid tumors to build a population pharmacokinetic model with Phoenix NLME software, screening for covariates affecting drug clearance. Total bilirubin and lean body weight were identified as statistically and clinically significant covariates affecting ORIN1001 clearance and steady-state exposure. This first population pharmacokinetic model for ORIN1001 provides an important reference for future dose-adjustment considerations in this investigational drug's continued development.
Author(s): Li X, Bo Y, Zeng Q, Diao L, Greene S, Patterson J, Liu L, Yang F
Published: 2024 年 3 月 4 日
Phoenix NLME：First Model for a New Molecule
Phoenix NLME built the first population PK model for this investigational IRE1-alpha inhibitor, identifying covariates to guide future dose selection. Phoenix NLME can be paired with Model Designer to select, configure, and simulate models directly in the browser, guided by an AI assistant, within a Phoenix platform cited in more than 33,000 peer-reviewed articles.
