GP681 in Volunteers With Hepatic Impairment Compared With Healthy Volunteers

Phase 1 Completed 24 enrolled Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to test whether mild (Child-Pugh A, score 5-6) and moderate (Child-Pugh B, score 7-9) hepatic impairment affects pharmacokinetics, safety and tolerability of GP681, compared with a control group with normal hepatic function following oral administration of GP681 as single dose.

Timeline

Start: 2023-04-26
Primary completion: 2023-08-03
Completion: 2023-10-20

Publications

Zhou J, Yan S, Zhao Y, Zhang H, Wang N. A phase I study to evaluate the effect of hepatic impairment on the pharmacokinetics and safety of suraxavir marboxil: a novel oral antiviral for influenza. Antimicrob Agents Chemother. 2026 May 6;70(5):e0166825. doi: 10.1128/aac.01668-25. Epub 2026 Mar 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	suraxavir	Small molecule	40 mg	Oral

Indications

No indication recorded.