Drug-drug Interaction Study Beteewn ASK120067 and Rifampicin or Itraconazole

Phase 1 Completed 48 enrolled Jiangsu Aosaikang Pharmaceutical Co., Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

To evaluate the effects of oral administration rifampicin or itraconazole capsules on the pharmacokinetics of ASK120067 and its metabolite CCB4580030 in healthy subjects. To evaluate the safety of ASK120067 tablets or combination with rifampicin capsules or itraconazole capsules in healthy subjects.

Timeline

Start: 2022-06-06
Primary completion: 2022-08-03
Completion: 2022-08-03

Publications

Cao B, Huang L, Liu M, Lin H, Ma T, Zhao Y, Geng Y, Yang Y, Guo H, Li J. Phase 1 study to evaluate the effects of rifampin or itraconazole on the pharmacokinetics of limertinib (ASK120067), a novel mutant-selective inhibitor of the epidermal growth factor receptor in healthy Chinese subjects. Expert Opin Drug Metab Toxicol. 2023 Sep;19(9):653-664. doi: 10.1080/17425255.2023.2260738. Epub 2023 Oct 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Limertinib	Small molecule	80 mg	Oral
Subject	Limertinib	Small molecule	160 mg	Oral
Subject	Rifampin	Small molecule	600 mg	Oral

Indications

No indication recorded.