A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

Phase 1 Completed 24 enrolled Jiangsu HengRui Medicine Co., Ltd.

NaSingle-groupOpen-labelBasic science

Summary

This is a drug-drug interaction study conducted in healthy volunteers to evaluate the pharmacokinetic effect of SHR0302 on CYP3A4, CYP2C9, CYP2C9, CYP2C19, using midazolam, s-warfarin, omeprazole, and repaglinide as probe drugs.

Timeline

Start: 2022-07-15
Primary completion: 2022-08-18
Completion: 2022-08-18

Publications

Fu M, Luo L, Feng S, Lin H, Lu Z, Gu F, Fan Y, Wu B, Huang J, Shen K. Effect of SHR0302 on the pharmacokinetics of CYP3A4, CYP2C8, CYP2C9 and CYP2C19 probe substrates in healthy volunteers: A cocktail analysis. Br J Clin Pharmacol. 2023 Dec;89(12):3659-3668. doi: 10.1111/bcp.15856. Epub 2023 Aug 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Midazolam	Small molecule	15 mg	Oral
Subject	Omeprazole	Other / unclassified	20 mg	Oral
Subject	Repaglinide	Small molecule	0.5 mg	—
Subject	SHR0302	Unknown	8 mg	Oral
Subject	Warfarin	Small molecule	5 mg	Oral
Background	Vitamin K	Unknown	—	—

A Pharmacokinetic Study to Evaluate the Drug Interaction Between SHR0302 and CYP Substrates in Healthy Volunteers

Summary

Timeline

Publications

Drugs

Indications