NCT06823258

Pharmacokinetic Study of HS-10365 Capsule in Subjects with Hepatic Impairment and Normal Hepatic Function

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• NSCLC (advanced Non-small Cell Lung Cancer)

Interventions

Type	Name	Description
DRUG	HS-10365	HS-10365 administered orally once at D1

Timeline

• Start date: 2025-02-28
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2025-02-12
• Last updated: 2025-02-12