PK outcomes
hepatic impairment, cirrhosis
HEPATIC IMPAIRMENT, CIRRHOSIS
As BI 685509 is expected to be primarily eliminated by the liver (unpublished data), it is anticipated that hepatic impairment may lower the overall clearance of BI 685509, leading to higher systemic exposure. Indeed, when compared with matched HVs, apparent clearance was ~27% and ~19% lower in CP-A and CP-B patients, respectively. In addition, BI 685509 total exposure in patients with hepatic impairment (AUCThe PK and safety data obtained from this Phase Ib study informed the study design and BI 685509 dose selection for 2 ongoing Phase II studies in patients with cirrhosis and clinically significant PH (NCT05161481 and NCT05282121).