A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liv… (NCT06272058) | Clinical Trial Compass
TerminatedPhase 1
A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems
Stopped: Sponsor decision
United States4 participantsStarted 2024-05-03
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 hepa…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: up to 6 days
2
Maximum measured concentration of the analyte in plasma (Cmax)