Effect of Age, Sex, Renal Impairment and Hepatic Impairment on the Safety, Pharmacokinetics and Pharmacodynamics of Asundexian.

ABSTRACT:

Introduction

Asundexian is a reversible and selective inhibitor of activated factor XI. It is currently under investigation for the prevention of secondary stroke in at-risk patients; these patients are often characterised by advanced age, impaired organ function and comorbidities. This article summarises results from three Phase I studies that investigated the effects of age and sex (study 1), chronic kidney disease including end-stage kidney disease (ESKD) on dialysis and dialysis-free days (study 2) and Child-Pugh A and B liver disease (study 3) on the safety, pharmacokinetics and pharmacodynamics of a single oral dose of asundexian 25 mg.

Methods

Study 1 was a multicentre, randomised, single-blind, placebo-controlled group-stratification design; study 2 was a single-cent

SUBMITTER: Brase C 

PROVIDER: S-EPMC11573861 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature