Who is eligible for clinical trial NCT07486102?

Participants must meet protocol criteria for Healthy. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07486102 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-05-13

A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems (NCT07486102)

🟢 Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Boehringer Ingelheim

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (9 items) and avoid the listed exclusions (13 items).

Location: American Research Corporation at the Texas Liver Institute — San Antonio, Texas

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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. Inclusion criteria Cohort 4 (participants with normal hepatic function) \- Clinically healthy based on medical history, physical examination, vital signs, Electrocardiogram (ECG), and laboratory tests at Visit 1. Inclusion criteria Cohorts 1, 2 and 3 (participants with hepatic impairment)
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.

Usually NOT eligible if any of the following apply:

Exclusion Criteria :
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.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

American Research Corporation at the Texas Liver Institute — San Antonio, Texas

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗