Pharmacokinetics, Safety, and Tolerability of DA-302168S Tablets in Participants With Hepatic Impairment and Normal Hepatic Function

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2026
This is an open-label, non-randomized study to assess how DA-302168S is absorbed, distributed, metabolized, and eliminated after a single oral dose. The study includes three groups: subjects with mild hepatic impairment (Child-Pugh Class A), subjects with moderate hepatic impairment (Child-Pugh Class B), and healthy subjects matched by gender, age, and body mass index (BMI). It will also explore the relationship between baseline liver function measures and the pharmacokinetic (PK) parameters of DA-302168S, to support appropriate dosing recommendations for patients with liver impairment.
Epistemonikos ID: 4787768a769ce021932fc643ed07f7bf8c64b2b8
First added on: Oct 16, 2026