Study design and participants
hepatic impairment, primary biliary cholangitis, cirrhosis, ascites
HEPATIC IMPAIRMENT, ASCITES, PRIMARY BILIARY CHOLANGITIS, EVENT, CIRRHOSIS, ORTHOSTATIC HYPOTENSION, PRIMARY SCLEROSING CHOLANGITIS
This single-center, randomized, placebo-controlled, double-blind (within dose groups), parallel-group, dose-escalation, Phase Ib study investigated 3 dosing schemes of BI 685509 in patients with mild or moderate hepatic impairment and compared single BI 685509 doses in patients with matched HVs. The planned enrolment was 64 participants: 48 patients with hepatic impairment (24 each per CP-A/CP-B), and 16 HVs.All eligible participants were aged ≥18 years, with a MAP of ≥85 mm Hg and an estimated glomerular filtration rate of >70 mL/min/1.73 mParticipants were excluded if they had ongoing chronic alcohol or drug use (which, in the investigator’s opinion, would have resulted in unreliable results or the inability to complete the trial), history of relevant orthostatic hypotension, major operation within 12 weeks prior to screening, primary sclerosing cholangitis, primary biliary cholangitis or HIV, or if they were pregnant or nursing. Patients with CP-B cirrhosis were excluded if they had refractory ascites or a recent decompensation event within 6 weeks of screening.All patients provided written informed consent before study enrollment, and these studies were conducted in accordance with Good Clinical Practice (CPMP/International Council on Harmonisation/135/95), ethical principles laid down in the 2013 Declaration of Helsinki, and applicable regulatory requirements.