A Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

Phase 1 Completed 32 enrolled Idorsia Pharmaceuticals Ltd.

Non-randomizedSequentialOpen-labelOther

Summary

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild, moderate, and severe hepatic impairment due to liver cirrhosis on the pharmacokinetics of ACT-541468.

Timeline

Start: 2018-02-26
Primary completion: 2020-02-27
Completion: 2020-02-27

Publications

Berger B, Dingemanse J, Sabattini G, Delahaye S, Duthaler U, Muehlan C, Krahenbuhl S. Effect of Liver Cirrhosis on the Pharmacokinetics, Metabolism, and Tolerability of Daridorexant, A Novel Dual Orexin Receptor Antagonist. Clin Pharmacokinet. 2021 Oct;60(10):1349-1360. doi: 10.1007/s40262-021-01028-8. Epub 2021 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Daridorexant	Small molecule	10 mg	Oral
Subject	Daridorexant	Small molecule	25 mg	Oral

Indications

No indication recorded.