BI 3000202 for Liver Disease

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Boehringer Ingelheim

Disqualifiers: Malignancy, Stem cell transplant, Tuberculosis, others

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

Compensation: Varies

Number of Visits: 11

Duration: 1 month

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems.

All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition.

Participants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.

Are You a Good Fit for This Trial?

Inclusion Criteria

Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to participation in the trial

Hepatic decompensation therapies must comply with specific requirements

I am healthy based on recent exams and lab tests.

Exclusion Criteria

Participation in another clinical trial within 30 days or 5 half-lives of the investigational drug prior to Visit 2

I have received a live vaccine in the past 8 weeks.

I have received a BCG vaccine in the past year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take 1 tablet of BI 3000202. Participants with liver problems may continue their regular treatment for their liver condition.

1 month

11 visits (some in-person, some by phone, some overnight stays)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BI 3000202

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+