NCT04423601

Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Subjects

A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of SHR6390 in Healthy Chinese Adult Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	SHR6390 tablet	single oral dose of SHR6390 or co-administered with itraconazole.
DRUG	Itraconazole capsule	200 mg itraconazole was administered in the morning.

Timeline

• Start date: 2020-06-10
• Primary completion: 2020-07-29
• Completion: 2021-02-02
• First posted: 2020-06-09
• Last updated: 2021-10-18

Locations

1 site across 1 country: China