New drug tested in people with liver disease
NCT ID NCT06957756
First seen Jun 26, 2026 · Last updated Jul 08, 2026 · Updated 3 times
Summary
This study looked at how the body handles a drug called BI 1584862 in people with different levels of liver function. 43 adults with mild, moderate, or severe liver problems, plus a group with healthy livers, took a single dose of the drug. Researchers measured drug levels in the blood and monitored safety to understand how liver impairment affects the drug's processing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 1584862
- What this could lead to
- If successful, this study could help doctors understand how to safely dose BI 1584862 in people with liver problems.
- What could go wrong
- This is an early phase 1 study with only 43 participants, so results may not apply to everyone. The drug's effectiveness is not being tested here.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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43 people
The number who actually took part.
- Started
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Aug 2025
- Finished
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May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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American Research Corporation
San Antonio, Texas, 78215, United States
-
Arizona Clinical Trials - Chandler
Chandler, Arizona, 85225, United States
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Omega Research Orlando, LLC
Orlando, Florida, 32808, United States
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Other studies related to the condition(s) this trial covers.
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