Actively Recruiting
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
Led by Boehringer Ingelheim · Updated on 2026-05-14
44
Participants Needed
1
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 80 years at first visit
- Signed informed consent according to ICH-GCP and local laws
- Male and female participants; women of childbearing potential must use highly effective contraception during the study and for 14 days after dosing
- Male participants with female partners of childbearing potential must use condoms or abstain from sex during the study and for 14 days after dosing
- Body mass index between 18.5 and 42.0 kg/m² at first visit
- Clinically healthy participants (for normal liver function group)
- Participants with liver impairment classified as Child-Pugh classes A, B, or C
- Stable liver treatments allowed if no major dose changes within 4 weeks and no initiation or permanent stop within 3 months before first visit
- Clinical condition must be controlled and suitable for trial participation
You will not qualify if you...
- Participation in another clinical trial within 30 days or 5 half-lives of a study drug before second visit
- Known allergy to BI 3000202 or its ingredients
- Active or suspected cancer or history of cancer within 5 years (except certain skin or cervical cancers treated over 3 years ago)
- Previous stem cell transplantation
- Live or attenuated vaccination within 8 weeks before second visit
- Bacillus Calmette-Guérin (BCG) vaccination within 1 year before second visit
- Current serious infections or infections needing antibiotics within 6 weeks before second visit
- Active tuberculosis
- Latent tuberculosis with positive test and incomplete treatment within past 3 years and 1 month before second visit
- Indeterminate or borderline tuberculosis test results without clear negative retest
- Positive purified protein derivative (PPD) skin test without completed treatment
- Additional exclusion criteria apply as detailed by the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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