Study of BI 3000202 in People With and Without Liver Problems
This study is looking at how the body handles a medicine called BI 3000202 in healthy people and people with liver problems. We want to see how much of the medicine gets into the blood and how long it stays there. Adults aged 18 to 80 can join. All participants will take one tablet of BI 3000202. If you have liver problems, you can continue your usual treatments. Doctors will regularly check the amount of BI 3000202 in your blood and monitor your health for any issues. The study aims to understand how liver health affects how this medicine works in the body.
- Study design
- This is an interventional study involving 44 participants, including healthy individuals and those with hepatic impairment (liver problems).
- What's involved
- You would be in the study for about one month, with approximately 11 visits to the study site. Some visits may be by phone, and some will require overnight stays.
- Compensation
- Not stated in the trial record.
- Follow-up
- Blood levels of the drug will be measured for up to 8 days after taking the medicine.
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NCT07486102
A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems
Recruiting
PHASE1Ages 18–80InterventionalTreatmentBoehringer Ingelheim
~44 participants
Updated 2026-05-14 on ClinicalTrials.gov
What's tested:BI 3000202
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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)
Measured over Up to 8 days
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesTexas1
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Adult participants ≥18 years and ≤80 years of age at Visit 1.
Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to participation in the trial.
Male and female participants. Women of childbearing potential must be willing and able to use a highly effective method of contraception per ICH M3 (R2) that results in a low failure rate (i.e. \<1% per year when used consistently and correctly) for the duration of the trial until at least 14 days after drug administration. Throughout the trial and for a period of at least 14 days after investigational medicinal product (IMP) administration, male participants with sexual partners who are women of child-bearing potential must use condoms or practice complete abstinence.
Body mass index (BMI) of 18.5-42.0 kg/m² (inclusive) at Visit 1.
Hepatic impairment that meets the criteria for Child-Pugh classes A (Cohort 1), B (Cohort 2), or C (Cohort 3).
Hepatic decompensation therapies (e.g., diuretics for ascites, lactulose for hepatic encephalopathy, nonselective betablockers for portal hypertension) need to comply with following requirements:
No new initiation or permanent discontinuation is permitted within 3 months prior to Visit 1.
Major dose modifications (\>50% change from baseline) within 4 weeks prior to Visit 1 are exclusionary.
Minor titrations consistent with standard clinical management are permitted, provided the investigator confirms that the patient's underlying condition is clinically controlled. Cases involving fluctuating hepatic directed regimens may be included only if both the investigator and the sponsor agree that the patient's clinical condition is controlled and suitable for trial participation.
Exclusion
Participation in another clinical trial within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior Visit 2.
Known hypersensitivity to BI 3000202 or any of its excipients.
Any documented active or suspected malignancy or history of malignancy within 5 years prior to Visit 1 (except appropriately treated basal cell carcinoma or squamous cell carcinoma of the skin, or in situ carcinoma of uterine cervix (treated \>3 years); patients with a remote history of malignancy (≥5 years prior) may be considered and must be discussed with sponsor on a case-by-case basis.
Have received stem cell transplantation.
Have received live or attenuated vaccination within 8 weeks prior to Visit 2.
Have received Bacillus Calmette-Guérin (BCG) vaccines ≤1 year prior to Visit 2.
Presence of relevant chronic or acute infections, including active systemic infection requiring antibiotics within 6 weeks prior to Visit 2.
Active or latent tuberculosis (TB).
Participants with active TB will always be excluded.
Participants with latent TB will be excluded if tested positive for Interferon-gamma release assay (IGRA) (QuantiFERON®-TB Gold Plus or T-SPOT®.TB) at Visit 1, not having completed appropriate treatment per local practice/guidelines for TB within the past 3 years and at least 1 month before Visit 2.
Participants with indeterminate QuantiFERON®-TB Gold Plus or borderline or invalid T-SPOT®. TB may be retested with IGRA (once) and will be excluded if retesting is inconclusive or positive.
Under exceptional circumstances and only after discussion with the sponsor, purified protein derivative (PPD) skin test can be performed if IGRA is not available. A PPD ≥10 mm (≥5 mm if receiving ≥15 mg/day prednisone or other immunosuppressant) is considered positive. Participants with a positive PPD are excluded unless they have completed treatment as above.
What this trial 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)Up to 8 days
- Maximum measured concentration of the analyte in plasma (Cmax)Up to 8 days