How BI 1584862 is taken up in people with and without liver problems

Pharmacokinetics, Safety and Tolerability of BI 1584862 in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Class A, B, and C) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomized, Single-dose, Parallel, Individual-matched Design Trial)

This trial will test how a single dose of BI 1584862 is processed in adults with and without mild, moderate, or severe liver problems.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 3 sites (Chandler, Arizona and 2 other locations)
• Trial ID: NCT06957756 on ClinicalTrials.gov

What this trial studies

This Phase 1, single-dose pharmacokinetic study gives one dose of BI 1584862 to adults with mild, moderate, or severe hepatic impairment and to matched adults without liver problems as controls. Participants are adults aged 18–80 with BMI 18–42 kg/m2 and may continue their usual liver treatments during the study. People with liver problems are dosed in a stepwise fashion with several days between cohorts so investigators can review safety data, and all participants attend three visits including a 4-night overnight stay over about five weeks. Blood samples and safety checks are collected to determine how liver impairment changes the drug’s absorption, distribution, and clearance.

Who should consider this trial

Good fit: Ideal participants are adults 18–80 years old with BMI 18–42 kg/m2 who either have documented mild, moderate, or severe hepatic impairment or are healthy matched controls and who can follow study procedures and contraception rules.

Not a fit: People who are pregnant or breastfeeding, have unstable or rapidly changing liver disease, major uncontrolled medical conditions, or who cannot comply with site visits and contraception requirements are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could guide safer dosing of BI 1584862 for people with different levels of liver impairment.

How similar studies have performed: Pharmacokinetic studies in people with liver impairment are standard and have successfully informed dosing recommendations for many drugs, though findings for this specific compound are new.

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.

Where this trial is running

Chandler, Arizona and 2 other locations

• Arizona Clinical Trials - Chandler — Chandler, Arizona, United States (Recruiting)
• Omega Research Orlando, LLC — Orlando, Florida, United States (Recruiting)
• American Research Corporation — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Hepatic Insufficiency