申请企业

DECIPHERA PHARMACEUTICALS LLC

药品名称

Qinlock (ripretinib)

状态

提交

承诺描述

Conduct a clinical pharmacokinetic trial to evaluate the effect of repeat doses of a strong CYP3A inducer on the single dose pharmacokinetics of ripretinib and DP-5439. 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.”This trial should determine the magnitude of decreased exposure of ripretinib and DP-5439 and an appropriate dosage recommendation for ripretinib when it is administered concomitantly with strong 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

2020/1/31 0:00:00

CDER/CBER

CD

子类型标记