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

A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of BI 3000202 in Adults

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Hepatic Impairment
• Intervention / Treatment: Drug: BI 3000202

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78215
      • Recruiting
      • American Research Corporation at The Texas Liver Institute
      • Contact: Boehringer Ingelheim; Phone Number: 833-602-2368; Email: unitedstates@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria :

• 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.

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.
  • 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.

Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Participants with mild hepatic impairment (Child-Pugh A)	Drug: BI 3000202; BI 3000202
Experimental: Participants with moderate hepatic impairment (Child-Pugh B)	Drug: BI 3000202; BI 3000202
Experimental: Participants with severe hepatic impairment (Child-Pugh C)	Drug: BI 3000202; BI 3000202
Experimental: Participants with normal hepatic function	Drug: BI 3000202; BI 3000202

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 8 days
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 8 days

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2026
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 27, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1509-0036; U1111-1324-2054 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No