Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of BI 1810631 (C‑14) oral solution, BI 1810631 (C‑14) IV microtracer, and BI 1810631 tablet to assess absorption and metabolism 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

The investigation involves a new compound called BI 1810631 that is being tested in healthy adult men. The compound is given in three ways: as a liquid taken by mouth called an oral solution, as a small pill known as a film-coated tablet, and as a very small dose injected into a vein, referred to as an intravenous microtracer. The liquid and the injected dose contain a tiny amount of a radioactive marker labeled C-14 to help track the drug inside the body.

The aim of the study is to understand how the body takes up, breaks down, and removes the drug, including how much of it reaches the bloodstream and how much is eliminated in waste. In the first part, participants receive the oral solution and provide samples of urine and feces over several days. In the second part, participants take the tablet while a microtracer dose is given by injection, and blood is drawn to measure the drug in plasma.

Researchers will calculate the total amount of drug recovered (mass balance), study its metabolism and overall movement through the body (pharmacokinetics), and determine the absolute bioavailability of the tablet form. The analysis includes measuring the overall exposure (AUC) and the highest concentration reached (Cmax) in the blood.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessments

    After joining the study, you will undergo basic health checks that include measuring vital signs, taking a blood sample, and providing urine. these assessments confirm that you meet the study requirements and create a reference point for later comparisons.

  2. Step 2

    Oral solution dose – part a

    You will receive a single dose of BI 1810631 (C-14) as an oral solution. the amount is 60 mg (milligrams). the dose is taken once, by mouth, on the scheduled study day.

  3. Step 3

    Sample collection after oral solution

    Following the oral solution, you will stay in the clinic while staff collect blood samples at several time points to track how the drug is absorbed and eliminated.

    You will also collect all urine and feces produced for a period that may extend up to several days. these specimens are used to measure how much of the radioactive label is recovered from the body.

  4. Step 4

    Completion of part a collection period

    Once the required urine, feces, and blood samples have been gathered, the part‑a portion of the study is finished. you may be asked to return any remaining study materials and receive a brief health check before moving to the next part.

  5. Step 5

    Oral tablet and intravenous microtracer dose – part b

    On a designated day, you will take a single oral tablet of BI 1810631. the tablet contains 60 mg and is swallowed with water.

    Immediately after the tablet, a very small intravenous (into a vein) dose of BI 1810631 (C-14) will be given. this microtracer dose is 100 µg (micrograms) in a solution for infusion. the purpose is to compare how much of the drug reaches the bloodstream when given by mouth versus directly into the vein.

  6. Step 6

    Blood sampling after part b doses

    After receiving both the tablet and the intravenous microtracer, multiple blood samples will be taken over several hours. these samples allow calculation of the drug’s overall exposure (area under the curve) and the highest concentration reached in the blood.

  7. Step 7

    Final assessments and study completion

    When all required samples have been collected, a final health check will be performed. any study equipment will be returned, and you will be informed that the study procedures are complete.

Who can join the trial?

4 criteria

  • Be a healthy man, as judged by the doctor after reviewing your full medical history, doing a physical exam, checking vital signs such as blood pressure (BP) and pulse rate (PR), performing a 12‑lead ECG (a test that records the heart’s electrical activity), and completing laboratory tests.
  • Be between 18 and 55 years old, including the ages of 18 and 55.
  • Have a body mass index (BMI) between 18.0 and 30.0 kg/m². BMI is a simple calculation that compares your weight to your height to see if you are underweight, normal weight, or overweight.
  • Provide a signed and dated written informed consent form that follows the international standards for good clinical practice (ICH‑GCP) and local laws before you can join the study.

Who cannot join the trial?

5 criteria

  • Any abnormal finding in the medical check‑up (including blood pressure, pulse rate or electrocardiogram (ECG)) that the doctor thinks is important.
  • Repeated measurements of blood pressure or pulse rate that are outside the normal limits: the top number (systolic blood pressure) must be between 90 and 145 mmHg, the bottom number (diastolic blood pressure) must be between 45 and 90 mmHg, and the pulse rate must be between 40 and 100 beats per minute (bpm).
  • Any laboratory test result (such as blood or urine tests) that is outside the normal range and the doctor considers it clinically relevant.
  • Any other disease or health problem that the doctor judges to be clinically relevant.
  • Any additional exclusion rules that are part of the study.
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 1810631 (C-14) oral solution

    is a liquid form of the investigational drug that contains a small amount of radioactive carbon (C‑14). In the study it is given as a single dose by mouth. The radio‑label lets researchers track where the drug goes in the body and how much of it is eliminated in urine and feces. This helps to understand the drug’s absorption, distribution, metabolism, and excretion.

  • BI 1810631 (C-14) intravenous microtracer

    is the same drug, also radio‑labelled, but it is given as a very small dose directly into a vein through an infusion. Because it is injected, it bypasses the digestive system, providing a reference measurement of how much of the drug reaches the bloodstream. This reference is used to compare with the oral tablet and calculate the drug’s absolute bioavailability.

  • BI 1810631 film‑coated tablet

    is the non‑radioactive, solid tablet form of the investigational drug taken by mouth. In the trial it is administered to healthy volunteers to see how much of the drug becomes available in the blood after oral dosing. Its performance is compared with the intravenous microtracer to determine the proportion of the oral dose that reaches systemic circulation.

What is already known about the treatment

  • BI 1810631 (C-14) oral solution

    This medication is taken by mouth as a liquid that is swallowed, delivering a 60 mg dose of the radiolabeled compound. It is currently an investigational drug being studied in early‑phase clinical trials and is not approved for any medical use. The product is being examined to understand how the body processes and eliminates it, with no specific therapeutic indication assigned yet. It is classified as an experimental small‑molecule agent whose exact molecular target is still under investigation.

  • BI 1810631 (C-14) solution for infusion

    This form is administered intravenously as a sterile infusion containing a very small 100 µg micro‑dose of the radiolabeled substance. It is also an investigational compound in phase‑I studies, not yet marketed or approved for treatment. The purpose of this dose is to compare how much of the drug reaches the bloodstream when given by IV versus oral routes, and it has no approved therapeutic use at this time. It belongs to the class of experimental small‑molecule drugs, with a mechanism of action that is still being defined.

  • BI 1810631 film‑coated tablet

    The tablet is taken by mouth, swallowed whole, delivering a 60 mg dose of the non‑radiolabeled compound. It is an investigational medication currently in phase‑I trials and has not received any regulatory approval. The study aims to learn how well the tablet is absorbed compared with the IV micro‑dose, and the drug has no established therapeutic indication yet. It is categorized as an experimental small‑molecule agent, and its precise molecular action is under research.

Investigated diseases

Healthy - A healthy person shows normal physical and mental function without signs or symptoms of disease. Body systems operate within typical ranges, and metabolic processes are balanced. The state remains stable unless external factors such as infection, injury, or lifestyle changes disturb it. Over time, a healthy individual may experience normal aging, which involves gradual physiological changes but not disease. Maintaining health involves sustaining this balance through adequate nutrition, activity, and rest.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-503047-17-00Protocol code1479-0006Estimated enrolment15 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).