Clinical Trial of FCN-437c Capsule in Patients With Hepatic Insufficiency

Summary

To evaluate and compare the safety and efficacy of FCN-437c in subjects with mild and moderate liver impairment and healthy subjects, and to provide a basis for clinical medication in patients with liver impairment.

Timeline

Start

2023-09-04

Primary completion

2023-09-27

Completion

2023-09-27

Publications

• Xu J, Liu J, Ding Y, Yang X, Fu Y, Sun Y. Safety and pharmacokinetics of FCN-437c, a novel cyclin-dependent kinase 4/6 inhibitor, in Chinese patients with hepatic impairment. Invest New Drugs. 2025 Aug;43(4):792-799. doi: 10.1007/s10637-025-01552-5. Epub 2025 Jul 15.

Drugs

Indications