Population pharmacokinetics of iruplinalkib in healthy volunteers and patients with solid tumors.

ABSTRACT: Iruplinalkib (WX-0593), a selective oral ALK/ROS1 tyrosine kinase inhibitor, was approved in China as first-line therapy for ALK-positive non-small-cell lung cancer (NSCLC) and for the treatment of locally advanced or metastatic ALK-positive NSCLC that has progressed following crizotinib therapy. Pharmacokinetics (PK) data of iruplinalkib have been collected in healthy subjects and patient populations in several studies. We developed a population PK (PopPK) model for describing iruplinalkib plasma concentrations and for evaluating whether dose adjustments are necessary based on demographic factors or disease characteristics. Plasma concentration-time data were collected from 392 participants (16 healthy volunteers and 372 patients with solid tumors) who received single or multiple doses of

SUBMITTER: Yang G 

PROVIDER: S-EPMC11671680 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature