a study to test how different doses of bi 685509 are tolerated in patients with liver problems

Conditions: Healthy; Hepatic Insufficiency

Summary: the primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[child-turcotte-pugh (ctp) classification a and b\] over different dose regimes of bi 685509 compared to placebo. a secondary objective is to investigate pharmacokinetics of different doses of bi 685509 in patients with mild to moderate hepatic impairment (ctp a and ctp b). in addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (ctp a and ctp b) of single bi 685509 dose to individually matched healthy volunteers


Eligibility criteria:
key inclusion criteria for all trial participants: * age ≥ 18 years at screening * male or female. women of childbearing potential (wocbp) participants and male participants able to father a child must be ready and able to use a highly effective method of birth control per ich m3 (r2) that results in a low failure rate of less than 1% per year when used consistently and correctly throughout the trial * mean arterial pressure (map) ≥ 85 mmhg at screening visit * estimated glomerular filtration rate (egfr) \> 70 ml/min/1.73m² according to the ckd-epi formula at screening visit * signed and dated written informed consent in accordance with ich-gcp and local legislation prior to admission to the trial key inclusion for patient groups 1 and 2 * if on treatment with non-selective beta blockers (nsbb), stable dose since ≥ 8 weeks prior to screening, with no planned dose change of the therapy during study conduct. all other medications stable 4 weeks prior to screening. * patient group 1: patients with ctp a and portal hypertension (defined as liver stiffness \>15 kpa during screening) and without a previous decompensation event \[ascites, variceal hemorrhage, encephalopathy, or jaundice (except gilbert's disease or hemolysis when bilirubin will be almost exclusively indirect hyperbilirubinemia)\]. self-limited and resolved historical events of decompensation like ascites or encephalopathy are allowed if they have occurred at least 6 weeks prior to screening and do not require continued therapeutic intervention at the time of screening. * patient group 2: patients with ctp b (with liver stiffness \>15 kpa during screening) key inclusion for healthy volunteer group * subjects who are healthy, according to the investigator's assessment, individually matched to a participant among patient groups 1 and 2 according to the following criteria: age within ± 5 years, body weight within ± 15%, and gender * further inclusion criteria apply key exclusion for all trial participants * ongoing chronic alcohol or drug use, which in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial. * history of relevant orthostatic hypotension, fainting spells, or blackouts based on the investigator´s judgment key exclusion for patient groups * patient group 2: treatment-refractory ascites * patient group 2: recent decompensation event (refractory ascites, recurrent variceal hemorrhage, recurrent hepatic encephalopathy, spontaneous bacterial peritonitis or hepatorenal syndrome) within 6 weeks of screening * further exclusion criteria apply