A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

Phase 1 Completed 17 enrolled Jiangsu HengRui Medicine Co., Ltd.

NaSingle-groupOpen-labelTreatment

Summary

This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole

Timeline

Start: 2022-01-04
Primary completion: 2022-01-21
Completion: 2022-06-09

Publications

Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	SHR8554	Unknown	1 mg	Intravenous

Indications

No indication recorded.