The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics

Phase 1 Completed 17 enrolled Idorsia Pharmaceuticals Ltd.

Non-randomizedSingle-groupOpen-labelOther

Summary

This is a prospective, open-label, single-dose, Phase 1 study, to assess the effect of moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of aprocitentan (ACT-132577).

Timeline

Start: 2020-06-26
Primary completion: 2021-04-05
Completion: 2021-05-06

Publications

Fontes MSC, Dingemanse J, Halabi A, Tomaszewska-Kiecana M, Sidharta PN. Single-dose pharmacokinetics, safety, and tolerability of the dual endothelin receptor antagonist aprocitentan in subjects with moderate hepatic impairment. Sci Rep. 2022 Nov 9;12(1):19067. doi: 10.1038/s41598-022-22470-z.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Aprocitentan	Small molecule	25 mg	Oral

Indications

No indication recorded.