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<p>This study explored the impact of hepatic impairment on the safety and pharmacokinetics (PK) of FCN-437c, a novel dual CDK4/6 inhibitor for potential breast cancer treatment. In an open-label trial, 25 subjects (8 with mild hepatic impairment, 8 with moderate hepatic impairment, and 8 healthy controls matched for age, sex, and body weight) received a single 200-mg dose of FCN-437c. Results showed that FCN-437c was generally well—tolerated, with no serious adverse events. In mild hepatic impairment group, total FCN-437c C<sub>max</sub> increased by 9.5%, while AUC<sub>0-t</sub> and AUC<sub>0-∞</sub> decreased by 4.8%. Free drug exposure increased by 24.7%, 8.4%, and 8.4%. In moderate hepatic impairment group, total FCN-437c C<sub>max</sub>, AUC<sub>0-t</sub>, and AUC<sub>0-∞</sub> decreased by 16.7%, 17.1%, and 15.7%, and free drug exposure increased by 47.8%, 47.0%, and 49.6%. Overall, no clinically relevant differences in FCN-437c exposure were found between subjects with mild or moderate hepatic impairment and normal controls, but moderate hepatic impairment increased free drug exposure. Thus, no dose adjustment is needed for patients with mild hepatic impairment, but a reduced dose may be necessary for those with moderate hepatic impairment. Trial Registration: <a href="http://www.clinicaltrials.gov/">www.clinicaltrials.gov</a>identifier NCT06620731 (retrospectively registered).</p>

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Safety and pharmacokinetics of FCN-437c, a novel cyclin-dependent kinase 4/6 inhibitor, in Chinese patients with hepatic impairment

  • 期刊论文

  • 发表日期：

    2025年7月15日

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  • Jia Xu,
  • Jingrui Liu,
  • Yanhua Ding,
  • Xiaoran Yang,
  • Yunjie Fu,
  • Yi Sun

摘要

This study explored the impact of hepatic impairment on the safety and pharmacokinetics (PK) of FCN-437c, a novel dual CDK4/6 inhibitor for potential breast cancer treatment. In an open-label trial, 25 subjects (8 with mild hepatic impairment, 8 with moderate hepatic impairment, and 8 healthy controls matched for age, sex, and body weight) received a single 200-mg dose of FCN-437c. Results showed that FCN-437c was generally well—tolerated, with no serious adverse events. In mild hepatic impairment group, total FCN-437c Cmax increased by 9.5%, while AUC0-t and AUC0-∞ decreased by 4.8%. Free drug exposure increased by 24.7%, 8.4%, and 8.4%. In moderate hepatic impairment group, total FCN-437c Cmax, AUC0-t, and AUC0-∞ decreased by 16.7%, 17.1%, and 15.7%, and free drug exposure increased by 47.8%, 47.0%, and 49.6%. Overall, no clinically relevant differences in FCN-437c exposure were found between subjects with mild or moderate hepatic impairment and normal controls, but moderate hepatic impairment increased free drug exposure. Thus, no dose adjustment is needed for patients with mild hepatic impairment, but a reduced dose may be necessary for those with moderate hepatic impairment. Trial Registration: www.clinicaltrials.govidentifier NCT06620731 (retrospectively registered).