Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

A study to test how BI 1291583 is broken down and removed from the body in healthy men

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves healthy men who do not have any disease. The research will test how a medicine called BI 1291583 moves through and is broken down by the body. The medicine will be given as an oral solution, which is a liquid that is swallowed. The study will use a special version of the medicine that contains a substance called C-14, which is a type of radioactive marker that allows researchers to track where the medicine goes in the body. The purpose of the study is to understand how the body processes this medicine and how much of it leaves the body through urine and stool.

Participants in this study will receive a single dose of BI 1291583 by mouth. After taking the medicine, samples of blood, urine, and stool will be collected at different times. These samples will be tested to measure the amount of medicine and its breakdown products in the body. The researchers will track how the medicine is absorbed, changed by the body, and removed from the body over time. This information will help scientists understand the way the medicine works and how it might be used in future treatments.

The study is described as open-label, which means that both the participants and the researchers will know what medicine is being given. Since this is a phase I trial, it is an early stage of testing that focuses on understanding how the medicine behaves in the body rather than treating a specific disease. The participants will be monitored throughout the study to collect the necessary information about how their bodies handle the medicine.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Admission and baseline assessment

    Upon joining the study, a complete medical history will be taken and a physical examination will be performed.

    Your vital signs will be measured, including blood pressure and pulse rate.

    A 12-lead ECG (electrocardiogram, a test that records the electrical activity of your heart) will be performed.

    Blood and urine samples will be collected for clinical laboratory tests to assess your health status.

  2. Step 2

    Administration of the study medication

    You will receive a single oral dose of BI 1291583 containing a small amount of radioactive carbon (C-14).

    The medication will be administered as an oral solution that you will take by mouth.

    This is a one-time dose, and you will not receive repeated doses during the study.

  3. Step 3

    Sample collection period

    After taking the medication, blood samples will be collected at specific time points to measure drug levels in your body.

    You will be required to collect all urine produced during the study period in provided containers.

    You will also be required to collect all faeces (stool) during the study period in provided containers.

    These samples will be analyzed to determine how the medication is processed and eliminated from your body.

    The collection period will continue until the levels of radioactivity are no longer measurable or have reached a very low level.

  4. Step 4

    Monitoring and observation

    Throughout the study, your health will be monitored regularly.

    Any changes in your condition will be documented and assessed.

    The study staff will track the amount of radioactivity eliminated from your body through urine and faeces to understand how completely the medication is removed.

  5. Step 5

    End of study assessment

    Once sufficient samples have been collected and the medication has been adequately eliminated from your body, a final assessment will be performed.

    This may include a physical examination, vital signs measurement, and laboratory tests to ensure your continued health.

    Your participation in the study will then be complete.

Who can join the trial?

4 criteria

  • You must be a healthy male person based on the doctor's evaluation, which includes a complete medical history, a physical examination, checking your vital signs (blood pressure and heart rate), a 12-lead ECG (a test that records the electrical activity of your heart), and laboratory tests of your blood and other body fluids
  • You must be between 18 and 55 years old
  • Your BMI (Body Mass Index, which is a measurement that compares your weight to your height) must be between 18.5 and 29.9 kg/m2
  • You must sign and date a written informed consent form (a document showing you understand and agree to participate in the study)

Who cannot join the trial?

4 criteria

  • Women cannot participate in this study, as it is only open to male subjects
  • People who are not healthy cannot participate, as the study requires healthy volunteers, which means individuals without any current medical conditions or diseases
  • Children and elderly people outside the specified age range cannot participate, as the study has specific age requirements for enrollment
  • People who belong to vulnerable populations cannot participate, which means individuals who may have limited ability to make their own decisions or who need special protection, such as prisoners, people with severe mental disabilities, or those in dependent relationships
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

BI 1291583 is an investigational medication being tested in this trial. It is given as a liquid that you drink (oral solution). In this study, the medication contains a special radioactive marker (called C-14) that helps researchers track how the body processes and eliminates the medication. This allows scientists to understand how the medication moves through the body, how it is broken down, and how it leaves the body through urine and stool.

What is already known about the treatment

BI 1291583 – BI 1291583 is an investigational medication currently being studied in early-phase clinical trials and is administered as an oral solution (liquid taken by mouth). This substance is in the experimental stage and is being tested in healthy volunteers to understand how the body processes it, including how it is broken down and eliminated through urine and feces. The trial uses a radioactively labeled version of the drug to track its movement through the body and identify its breakdown products. The specific therapeutic use and exact mechanism of action have not yet been established, as this phase I study focuses on understanding the basic safety and metabolism of the compound in humans.

Investigated diseases

Healthy – This designation indicates that the study participants do not have any disease or medical condition. Healthy volunteers are individuals who are free from illnesses and do not exhibit symptoms of any disorders. They participate in clinical trials to help researchers understand how medications or treatments work in people without underlying health problems. These participants typically undergo screening to confirm they meet specific health criteria before joining a study. Their involvement helps establish baseline data and safety profiles for new medications. Healthy volunteers play a crucial role in early-phase clinical research.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502264-20-00Protocol code1397-0016Estimated enrolment8 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).