Safety and Pharmacokinetics/Pharmacodynamics of HSK3486 in Patients With Hepatic Impairment

Phase 1 Completed 24 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd The First Hospital of Jilin University · collab

Non-randomizedParallel-groupOpen-labelDiagnostic

Summary

Comparison of the pharmacokinetics/Pharmacodynamics of the HSK3486 in Patients With Mild and Moderate Hepatic Impairment Compared with Healthy Volunteers

Timeline

Start: 2019-11-14
Primary completion: 2020-04-20
Completion: 2020-07-13

Publications

Results Qin L, Ren L, Wan S, Liu G, Luo X, Liu Z, Li F, Yu Y, Liu J, Wei Y. Design, Synthesis, and Evaluation of Novel 2,6-Disubstituted Phenol Derivatives as General Anesthetics. J Med Chem. 2017 May 11;60(9):3606-3617. doi: 10.1021/acs.jmedchem.7b00254. Epub 2017 Apr 28.
Hu Y, Li X, Liu J, Chen H, Zheng W, Zhang H, Wu M, Li C, Zhu X, Lou J, Yan P, Wu N, Liu X, Ma S, Wang X, Ding Y, Xuan C. Safety, pharmacokinetics and pharmacodynamics of a novel gamma-aminobutyric acid (GABA) receptor potentiator, HSK3486, in Chinese patients with hepatic impairment. Ann Med. 2022 Dec;54(1):2769-2780. doi: 10.1080/07853890.2022.2129433.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Cipepofol	Small molecule	0.4 mg/kg	Intravenous

Indications

No indication recorded.