申请企业

DECIPHERA PHARMACEUTICALS LLC

药品名称

Qinlock (ripretinib)

状态

未间断

承诺描述

Conduct a clinical pharmacokinetic trial to evaluate the effect of repeat doses of ripretinib on the single dose pharmacokinetics of a sensitive CYP2C8 substrate. This trial should be designed and conducted in accordance with the FDA Guidance for Industry titled, “Clinical Drug Interaction Studies – Study Design, Data Analysis, and Clinical Implications.” The results from this trial should determine the magnitude of increase in the exposure of the CYP2C8 substrate and an appropriate dosing recommendation of CYP2C8 substrates when they are administered concomitantly with ripretinib and may inform labeling.

承诺状态描述

报告接收日期

批准日期

2020/5/15 0:00:00

截止日期

2022/3/31 0:00:00

CDER/CBER

CD

子类型标记

F