Actively Recruiting
A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Liver Impairment on BI 3000202 in Adults
Led by Boehringer Ingelheim · Updated on 2026-05-14
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the body absorbs and processes a medicine called BI 3000202 in adults aged 18 to 80 years, including both healthy individuals and those with liver problems. The goal is to understand the effects of different levels of liver impairment on the drug's behavior in the body. This is a Phase I, open-label study led by Boehringer Ingelheim focusing on safety and tolerability as well as drug levels in the blood. All participants take a single tablet of BI 3000202. Those with liver problems may continue their usual liver treatments during the study. Participants are grouped based on liver function levels, ranging from normal to severe hepatic impairment. The study lasts about one month, with around 11 visits to the study site, some of which may be done by phone. Certain visits require an overnight stay. During the study, doctors regularly measure the amount of BI 3000202 in the participants' blood to assess how the drug is processed. Health checks are performed to monitor safety. The main outcomes include measuring the drug concentration over time and the highest concentration reached in the blood within up to eight days after dosing. Participants will be closely observed throughout their involvement, which lasts about one month in total.
CONDITIONS
Brief 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 the first visit
- Signed informed consent according to clinical standards
- Male and female participants included
- Women of childbearing potential must use effective contraception during the study and for 14 days after dosing
- Men with partners who can become pregnant must use condoms or abstain during the study and for 14 days after dosing
- Body mass index between 18.5 and 42.0 kg/m² at the first visit
- Participants with normal liver function must be clinically healthy based on medical history, exams, ECG, and lab tests
- Participants with liver impairment must meet Child-Pugh classes A, B, or C criteria
- Liver treatments must be stable with no new starts or permanent stops in the 3 months prior to the first visit
- Major dose changes (>50%) in liver treatments are not allowed within 4 weeks prior to the first visit
- Minor dose adjustments of liver treatments are allowed if the condition is clinically controlled
You will not qualify if you...
- Participation in another clinical trial within 30 days or 5 half-lives of an investigational drug before the second visit
- Known allergy to BI 3000202 or its ingredients
- Active or suspected cancer or cancer history within 5 years except certain treated skin or cervical cancers
- Previous stem cell transplantation
- Live or attenuated vaccination within 8 weeks before the second visit
- Bacillus Calmette-Guérin (BCG) vaccine within 1 year before the second visit
- Active infections needing antibiotics within 6 weeks before the second visit
- Active or latent tuberculosis unless properly treated and confirmed by tests
- Other exclusion criteria may apply based on additional assessments
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 days
Participants receive a single dose of BI 3000202 to evaluate its uptake in the blood, with assessments to monitor drug concentration and liver function.
Multiple visits over 8 days for blood sampling and monitoring
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
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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