NCT04252495

The Effect of Hepatic Impairment on Aprocitentan Pharmacokinetics

An Open-label Phase 1 Study to Investigate the Effect of Moderate Hepatic Impairment Due to Liver Cirrhosis on the Pharmacokinetics of a Single Dose of 25 mg Aprocitentan

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 30 Years – 79 Years
• Healthy volunteers: Accepted

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).

Conditions

• Hepatic Impairment
• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Aprocitentan	A single oral dose of 25 mg.

Timeline

• Start date: 2020-06-26
• Primary completion: 2021-04-05
• Completion: 2021-05-06
• First posted: 2020-02-05
• Last updated: 2022-11-23

Locations

2 sites across 2 countries: Germany, Poland