BI 1584862 for Liver Failure

Recruiting at 2 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Uncontrolled diabetes, Severe renal, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 1 week

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild, moderate, and severe liver problems affect how the body handles a medicine called BI 1584862. Participants take BI 1584862 once. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and to make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 3 times. This also includes an overnight stay for 4 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the site staff regularly takes blood samples.

Are You a Good Fit for This Trial?

Adults aged 18-80 with a BMI of 18-42 kg/m2 can join this study, which includes those with varying degrees of liver problems and healthy individuals for comparison. Participants must be sexually abstinent or use contraception, and provide informed consent.

Inclusion Criteria

I meet all the required conditions to participate.

I am either male or female.

My BMI is between 18.0 and 42.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants take a single dose of BI 1584862. Participants with liver problems are treated in a step-by-step approach with a few days in between for data review and tolerance assessment.

1 week

1 visit (in-person), includes an overnight stay for 4 nights

Follow-up

Participants are monitored for safety and effectiveness after treatment. Health checks and blood samples are taken to assess study endpoints.

3 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BI 1584862

Trial Overview The trial is testing how the body processes BI 1584862 in people with different levels of liver health. It involves one dose of the medication, step-by-step treatment for those with liver issues, regular health checks, blood samples collection, and a few overnight stays.

How Is the Trial Designed?

Group I: Participants with severe hepatic impairment (Child-Pugh C) Experimental Treatment 1 Intervention

Group II: Participants with normal hepatic function Experimental Treatment 1 Intervention

Group III: Participants with moderate hepatic impairment (Child-Pugh B) Experimental Treatment 1 Intervention

Group IV: Participants with mild hepatic impairment (Child-Pugh A) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+