A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems

NCT06272058 | Terminated Phase 1 FDA Drug

• 1 other identifier: 1366-0034
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2. Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet. Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

Healthy; Liver Diseases

Outcome Measures

Primary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

  up to 6 days

• Maximum measured concentration of the analyte in plasma (Cmax)

  up to 6 days

Secondary Outcomes (2)

• Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

  up to 6 days

• Occurrence of any treatment-emergent adverse event assessed as drug-related by the investigator

  up to 6 days

Study Arms (2)

Avenciguat (BI 685509) severe hepatic impairment (Child-Pugh C)

EXPERIMENTAL

Drug: Avenciguat (BI 685509)

Avenciguat (BI 685509) normal hepatic function

EXPERIMENTAL

Drug: Avenciguat (BI 685509)

Interventions

Avenciguat (BI 685509) DRUG

Avenciguat (BI 685509)

Avenciguat (BI 685509) normal hepatic function; Avenciguat (BI 685509) severe hepatic impairment (Child-Pugh C)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects aged ≥18 and ≤80 years at screening
• Body mass index (BMI) of 18.5 to 42 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 30 days after trial completion:
• Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
• Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
• Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
• Sexually abstinent
• A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
• Surgically sterilised (including hysterectomy)
• Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)
• Applying only to participants with impaired hepatic function:
• Stable hepatic impairment (Child-Pugh score 10 - 15 point consistent with severe hepatic impairment) due to parenchymal liver disease, which is confirmed and documented by at least one of the following: medical history, physical examination, hepatic ultrasound, computed tomography (CT) scan, magnetic resonance imaging (MRI), and/or liver biopsy and defined as no clinically significant change in disease status within 4 weeks, as judged by the Investigator
• Absence of significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment.
• Applying only to healthy participants with normal hepatic function:

You may not qualify if:

• Any medical condition or finding in the medical examination that in the investigator's opinion assessed as clinically relevant, poses a safety risk for the subject or may interfere with the study objectives (except for conditions associated with hepatic impairment in subjects with compromised hepatic function)
• Repeated measurement of systolic blood pressure outside the range of 100 to 150 millimetre(s) of mercury (mmHg), diastolic blood pressure outside the range of 70 to 100 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
• Any surgical or medical condition that may significantly interfere with the pharmacokinetics of the trial medication (eg, prior bariatric surgery, gastrectomy, ileal resection)
• History of relevant orthostatic hypotension, fainting spells, or blackouts
• History of relevant allergy or hypersensitivity (including allergy to the trial medication or its excipients)
• Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin
• Intake of restricted concomitant therapy or any concomitant therapy considered likely (based on Investigator judgement) to interfere with the safe conduct or may influence the primary and/or secondary endpoints of the trial within 30 days or 5 half-lives whichever longer prior to planned administration of the trial medication.
• Ongoing chronic alcohol or drug use, that in the investigator's opinion, makes the patient an unreliable trial participant or unlikely to complete the trial.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Liver Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: May 3, 2024
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)