drugset
drugset / Trial / NCT04423601

Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

NCT04423601 ↗

Phase 1 Completed 18 enrolled Jiangsu HengRui Medicine Co., Ltd.
NaSingle-groupOpen-labelBasic science

Summary

The primary objective of the study is to evaluate the effect of itraconazole on pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390 tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and when co-administered with itraconazole. The exploratory objective of the study is to explore the effect of SHR6390 related metabolic enzymes and transporter gene polymorphisms on the pharmacokinetics of SHR6390.

Timeline

Start
2020-06-10
Primary completion
2020-07-29
Completion
2021-02-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule — Oral
Subject Itraconazole Small molecule 200 mg Oral

Indications

No indication recorded.