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CompletedNCT06957756Updated Jul 7, 2026

A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems

A Phase 1 interventional study of BI 1584862 in Hepatic Insufficiency, sponsored by Boehringer Ingelheim. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Non-randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild, moderate, and severe liver problems affect how the body handles a medicine called BI 1584862.

Participants take BI 1584862 once. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and to make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study.

Participants are in the study for about 5 weeks. During this time, they visit the study site 3 times. This also includes an overnight stay for 4 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the site staff regularly takes blood samples.

02

Conditions studied

  • Hepatic Insufficiency

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03

In context

Hepatic Insufficiency

325 studies on the registry are indexed under Hepatic Insufficiency; 53 are open to participants now.

This study's enrollment of 43 is above the median of 36 across 220 interventional studies indexed under Hepatic Insufficiency.

Browse Hepatic Insufficiency studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria:

Inclusion criteria applicable to all participants

  • Male or female participants
  • Age of 18 to 80 years (inclusive)
  • Body mass index (BMI) of 18.0 to 42 kg/m2 (inclusive)
  • Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
  • Men participants must be willing and able to use contraception (condom, abstinence) from time point of administration of trial medication until 3 days after drug administration to prevent pregnancy and/or exposure of an existing embryo or fetus to the investigational product. Female partners do not need to use contraception
  • Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 30 days after administration of trial medication. The following methods of contraception are considered adequate for female participants of childbearing potential:

    • Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
    • Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS)
    • Sexually abstinent (true abstinence, in line with the preferred and usual lifestyle of the subject)
    • A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant.

Female participants are not considered to be of childbearing potential if they are either surgically sterilised (including hysterectomy) or postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle stimulating hormone (FSH) above 40 U/L and oestradiol below 30 ng/L is confirmatory).

Further inclusion criteria apply.

Exclusion criteria:

Exclusion criteria for all participants

  • Any medical condition or finding in the medical examination (including blood pressure (BP), pulse rate (PR) or Electrocardiogram (ECG)) assessed as clinically relevant by the investigator (apart from any hepatic impairment and associated underlying diseases)
  • Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
  • Any evidence of a concomitant disease assessed as clinically relevant by the investigator (apart from underlying disease)
  • For diabetics only: uncontrolled diabetes mellitus with an Hemoglobin A1c (HbA1c) > 9
  • Severe gastrointestinal, renal (Estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) \<40 ml/min/1.73 m2 for the hepatic impaired patients and eGFR CKD-EPI \<90 ml/min/1.73 m2 for matched controls), respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the Investigator.
  • Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • History of relevant orthostatic hypotension, repetitive fainting spells, or repetitive blackouts
  • Relevant chronic or acute infections Further exclusion criteria apply.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    Participants with mild hepatic impairment (Child-Pugh A)

    Drug: BI 1584862

  • Experimental
    Participants with moderate hepatic impairment (Child-Pugh B)

    Drug: BI 1584862

  • Experimental
    Participants with severe hepatic impairment (Child-Pugh C)

    Drug: BI 1584862

  • Experimental
    Participants with normal hepatic function

    Drug: BI 1584862

Interventions

  • DrugBI 1584862

    BI 1584862

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: up to 4 days

  2. Maximum measured concentration of the analyte in plasma (Cmax)

    Time frame: up to 4 days

Secondary outcomes

  1. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: up to 4 days

07

Study locations

3 sites
  • Arizona Clinical Trials - Chandler
    Chandler, Arizona 85225, United States
  • Omega Research Orlando, LLC
    Orlando, Florida 32808, United States
  • American Research Corporation
    San Antonio, Texas 78215, United States
08

References and documents

Related links

Individual participant data

Plan to share: No — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06957756
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
May 4, 2025
Start date
Aug 6, 2025
Primary completion
May 21, 2026
Completion
May 21, 2026
Last update
Jul 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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