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Study of BI 1810631 oral bioavailability in healthy men under fed vs fasted conditions

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The investigation enrolls healthy adult men and focuses on the experimental medication BI 1810631, which is taken as a film‑coated tablet by mouth (oral). The study compares how the drug is absorbed when a meal is eaten beforehand (fed condition) versus when the stomach is empty (fasted condition). Absorption is measured by looking at the drug’s bioavailability, which describes how much of the medication reaches the bloodstream after it is taken.

The purpose of the study is to determine the relative bioavailability of a single dose of the test drug under fed and fasted circumstances. Participants receive one dose in each condition, with a break between the two periods, and blood samples are collected to assess how the drug behaves in the body. The main measurements include the total drug exposure over time, expressed as the area under the concentration‑time curve (AUC0-tz), and the highest concentration reached in the blood (Cmax); a secondary measure looks at the exposure extrapolated to infinity (AUC0-∞). These values help researchers understand how food affects the amount of medication that becomes available to the body.

The research process

The trial runs in 10 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Join the study

    You have agreed to take part in a research study that examines how a single dose of a medication is absorbed when taken with food or without food.

  2. Step 2

    Baseline assessment and randomisation

    Initial health checks are performed to confirm eligibility.

    You are randomly assigned to receive the medication first under either the fed condition (taken with a standard meal) or the fasted condition (taken after an overnight fast).

  3. Step 3

    Preparation for the first dose

    If you are assigned to the fasted condition, you will avoid eating for at least ten hours before the dose.

    If you are assigned to the fed condition, you will eat a standard meal before taking the medication.

  4. Step 4

    First medication administration

    You swallow one film‑coated tablet of bi 1810631 containing 240 mg of the active substance.

    The tablet is taken by mouth only once for this period.

  5. Step 5

    Blood sampling after the first dose

    Blood samples are collected at several time points to measure how much of the drug reaches the bloodstream, which is called bioavailability.

  6. Step 6

    Washout period

    After the first set of measurements, there is a period without any study medication to allow the drug to leave your system before the next dose.

  7. Step 7

    Preparation for the second dose

    You will now follow the opposite condition from the first period: if the first dose was taken fasted, the second will be taken fed, and vice versa.

    The same preparation rules apply (fasting or eating a standard meal).

  8. Step 8

    Second medication administration

    You swallow another single 240 mg tablet of bi 1810631, this time under the opposite condition.

  9. Step 9

    Blood sampling after the second dose

    Additional blood samples are taken to compare the drug’s absorption between the fed and fasted states.

  10. Step 10

    Final assessment

    A final health check is performed to ensure you have returned to your normal condition before leaving the study.

Who can join the trial?

4 criteria

  • Be a healthy man, as decided by the doctor after reviewing a full medical history, a physical check‑up, vital signs such as blood pressure (BP) – the force of blood against artery walls, and pulse rate (PR) – how many times the heart beats per minute, a 12‑lead ECG (a test that records the heart’s electrical activity), and routine lab tests.
  • Be between 18 and 55 years old, inclusive.
  • Have a body mass index (BMI)
  • Provide a signed and dated written informed consent, meaning you agree to take part after understanding the study, in line with ICH‑GCP (international guidelines that protect participants’ rights and safety).

Who cannot join the trial?

5 criteria

  • Any abnormal result found during the medical exam (including blood pressure, pulse rate or an ECG test) that the doctor decides is important.
  • Repeated measurements of blood pressure or pulse that are outside the normal limits: systolic (top number) 90‑140 mmHg, diastolic (bottom number) 50‑90 mmHg, or pulse rate (heart beats per minute) 45‑90 bpm.
  • Any laboratory test (blood, urine, etc.) result that is outside the normal range and that the doctor considers to be significant.
  • Any other disease or health condition that the doctor judges to be relevant for the study.
  • Other exclusion rules that are not listed here but may also prevent participation.
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Investigated drugs

BI 1810631 is an oral, film‑coated tablet being tested to see how much of the drug reaches the bloodstream when taken with food (fed) compared with on an empty stomach (fasted). In this study, healthy male volunteers each take a single dose of the tablet, and researchers measure the drug levels in their blood to compare the two conditions. The purpose is to learn how food affects the drug’s absorption, which will help decide the best way to use the medication in everyday life.

What is already known about the treatment

BI 1810631 - This medication is given as a film‑coated tablet taken by mouth, with a single 240 mg dose used in the study. It is an investigational compound that is still in early clinical testing and has not yet been approved for any medical use. The trial is evaluating its safety and how the body absorbs the drug, but no specific therapeutic indication has been confirmed. BI 1810631 is classified as an experimental small‑molecule oral agent, and its exact molecular mechanism is still being studied.

Investigated diseases

Healthy volunteer trial - A healthy volunteer trial enrolls individuals who have no known medical conditions and are not taking regular medication. The participants are expected to maintain their normal physiological status throughout the study period. Because they are free of disease, there is no disease progression to observe. The trial monitors how the body handles the test substance under fed and fasted conditions. Any changes are limited to normal variations in metabolism and are not related to illness.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2022-502860-19-00Protocol code1479-0010Estimated enrolment16 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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