A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
64 participants in 4 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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