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Vasodilator

Avenciguat (BI 685509) normal hepatic function for Liver Disease

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 days

Awards & highlights

Study Summary

This trial is testing a new medication called Avenciguat (BI 685509) to treat high blood pressure in the portal vein. They are looking at how people with liver problems metabolize the

Who is the study for?

This trial is for adults aged 18-80 with a BMI of 18.5 to 42 kg/m2, who can be healthy or have severe liver problems. Participants must use reliable contraception if applicable and give informed consent. It's not suitable for those outside the age and BMI range or who don't meet the contraceptive requirements.Check my eligibility

What is being tested?

The study tests how Avenciguat (BI 685509), a potential treatment for high blood pressure in the portal vein, is absorbed by people with and without liver issues. Participants take one dose as a tablet and undergo health checks including blood measurements over slightly more than a month.See study design

What are the potential side effects?

While specific side effects are not listed, participants' health will be monitored regularly to identify any unwanted effects of taking Avenciguat (BI 685509).

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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)

Maximum measured concentration of the analyte in plasma (Cmax)

Secondary outcome measures

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

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Avenciguat (BI 685509) severe hepatic impairment (Child-Pugh C)Experimental Treatment1 Intervention

Group II: Avenciguat (BI 685509) normal hepatic functionExperimental Treatment1 Intervention

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor

2,507 Previous Clinical Trials

11,340,891 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include individuals above the age of 50?

"Individuals aged 18 years and above but below 80 are eligible to participate in this trial."

Answered by AI

What is the risk level of Avenciguat (BI 685509) in individuals with severe liver damage (Child-Pugh C)?

"Based on our evaluation at Power, the safety rating for Avenciguat (BI 685509) in severe hepatic impairment (Child-Pugh C) is a level 1 due to being classified as a Phase I trial with restricted evidence supporting both its safety and effectiveness."

Answered by AI

What is the current number of participants enrolled in this research endeavor?

"Yes, the details on clinicaltrials.gov suggest that this trial is presently in search of volunteers. The trial was initially listed on 3/20/2024 and most recently revised on 3/22/2024. At present, the study aims to enroll 16 participants at a single research site."

Answered by AI

Is the enrollment phase for this investigation currently ongoing?

"Affirmative. Details on clinicaltrials.gov confirm the ongoing recruitment of participants for this medical study. The trial was originally posted on March 20th, 2024 and underwent its latest revision on March 22nd, 2024. It is seeking to enroll a total of 16 individuals at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06272058.

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