Status:
COMPLETED
A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Healthy
Hepatic Insufficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 differen...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2021
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT03842761
Start Date
March 6 2019
End Date
May 20 2021
Last Update
June 10 2021
Active Locations (1)
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1
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215