NCT04406896

The Effect of Reduced Liver Function on Selatogrel Pharmacokinetics

An Open-label, Single-dose, Phase 1 Study to Evaluate the Pharmacokinetics of Selatogrel in Subjects With Mild and Moderate Hepatic Impairment Compared to Matched Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, single-center, open-label, single-dose, Phase 1 study, to assess the effect of mild and moderate hepatic impairment due to liver cirrhosis on the pharmacokinetics of selatogrel (ACT-246475).

Conditions

• Healthy Subjects
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Selatogrel	A single subcutaneous injection of 16 mg.

Timeline

• Start date: 2020-07-22
• Primary completion: 2020-10-23
• Completion: 2020-10-23
• First posted: 2020-05-29
• Last updated: 2025-07-04

Locations

1 site across 1 country: Germany