申请企业

DECIPHERA PHARMACEUTICALS LLC

药品名称

Qinlock (ripretinib)

状态

提交

承诺描述

Conduct a physiologically-based pharmacokinetic modeling/simulation study to assess the effect of repeat doses of a moderate CYP3A inducer on the single dose pharmacokinetics of ripretinib and DP-5439. This study should be designed and conducted in accordance with the FDA Guidance for Industry titled, “Physiologically Based Pharmacokinetic Analyses —Format and Content Guidance for Industry.” This study should estimate the magnitude of decrease in the exposure of ripretinib and DP-5439 and determine an appropriate dosage recommendation for ripretinib when it is administered concomitantly with moderate CYP3A inducers. The results from this study may inform product 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

2021/1/31 0:00:00

CDER/CBER

CD

子类型标记