drugset / Trial / NCT06823245

Pharmacokinetic Study of HS-10241 Tablets in Subjects with Hepatic Impairment and Normal Hepatic Function

NCT06823245

Phase 1 Not yet recruiting 32 enrolled Jiangsu Hansoh Pharmaceutical Co., Ltd.
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This study will be conducted in subjects with moderate Hepatic Impairment, mild hepatic Impairment and normal hepatic function. The study will be conducted in two stages. Based on the research results of moderate hepatic Impairment and matched control subjects with normal hepatic function, the sponsor will make a comprehensive analysis to decide whether it is necessary to conduct a study on the mild hepatic Impairment and matched control subjects with normal hepatic function.

Timeline

Start
2025-02-28
Primary completion
2025-07-31
Completion
2025-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-10241 Small molecule 300 mg Oral