NCT03713242

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

A Single-center, Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of ACT-541468 in Subjects With Mild, Moderate, and Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Idorsia Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	ACT-541468 25 mg	Administered as a tablet.
DRUG	ACT-541468 25 mg (or 10 mg depending on interim results)	Administered as a tablet.

Timeline

• Start date: 2018-02-26
• Primary completion: 2020-02-27
• Completion: 2020-02-27
• First posted: 2018-10-19
• Last updated: 2020-07-02

Locations

1 site across 1 country: Switzerland

Regulatory

• FDA-regulated drug study