Clinical Study on Pharmacokinetics of FCN-437c Capsule and Its Effect on QT Interval in Healthy Subjects

Summary

This is a single-center, randomized, double-blind, placebo-controlled Phase I clinical trial in healthy subjects.In healthy subjects, 300mg and 400mg FCN-437c capsules were taken orally for a single time. C-QTc effect model was used to evaluate the influence of blood concentration on QT interval, and the pharmacokinetic characteristics and safety of FCN-437c were also evaluated.Based on the C-QTc effect model, this study quantitatively analyzed the relationship between ΔΔQTcF and blood concentration, and evaluated the upper limit of 90% bilateral confidence interval of ΔΔQTcF corresponding to the geometric mean of Cmax at clinically relevant dose of FCN-437c capsule. This study plans to set up 2 dose groups, low-dose group 300mg and high-dose group 400mg.Nine healthy subjects were planned to be enrolled in each dose group, with a 2:1 ratio of placebo control. This study was carried out in the order of dose from low to high. After the administration of the low-dose group (300mg) and the safety assessment on the fourth day after administration, the study of the high-dose group (400mg) was decided through comprehensive evaluation.

Timeline

Start

2022-11-11

Primary completion

2023-02-08

Completion

2023-02-08

Publications

• Zhao L, Sun Y, Yang X, Tian L, Li L, Wang F, Niu X, Diao L, Li H. No QTc prolongation with CDK 4/6 inhibitor FCN-437c: results of a concentration-QTc analysis from a dedicated study in adult healthy subjects. Front Pharmacol. 2024 Aug 12;15:1433663. doi: 10.3389/fphar.2024.1433663. eCollection 2024.

Drugs

Indications