Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Effect of itraconazole on the pharmacokinetics of BI 1584862 in healthy male volunteers

Verified siteRegistered drugNo placebo
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 trial enrolls healthy adult men and examines how a medicine called itraconazole, taken as a liquid, influences the behavior of an experimental drug identified as BI 1584862, which is taken as a small tablet. No specific disease is being treated; the participants are volunteers who are in good health.

The purpose of the study is to find out whether a strong blocker of the body’s CYP3A4 enzyme, which normally helps break down many medicines, changes the amount of the test drug that reaches the bloodstream after a single dose.

Participants will first receive the test drug alone, then after a short interval they will take the enzyme blocker for several days before receiving the test drug again. Blood samples will be collected at various times to see how much of the test drug is present, and the whole process takes place over a few weeks.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial study visit

    You attend the study site and sign the consent form that explains the purpose of the trial.

    A brief health assessment is performed to confirm that you meet the criteria for a healthy volunteer trial.

    The study schedule, including the timing of medication and blood sampling, is explained to you.

  2. Step 2

    First administration of <b>bi 1584862</b>

    You take one 20 mg film‑coated tablet of bi 1584862 by mouth as a single dose.

    After the dose, blood samples are drawn at several time points to measure how much of the drug appears in your blood.

    The measurements focus on the area under the concentration‑time curve (auc) and the maximum concentration (cmax), which describe overall exposure and the highest level of the drug in the blood.

  3. Step 3

    Second administration phase with <b>itraconazole</b>

    You take the oral solution of itraconazole at a dose of 200 mg by mouth as instructed by the study protocol.

    Once the itraconazole dosing period is complete, you take a second single dose of bi 1584862 (20 mg tablet) in the same manner as before.

    Blood samples are again collected at multiple time points to compare the drug levels with those from the first administration.

    itraconazole is a strong cyp3a4 inhibitor; this means it can change the way the body processes other medicines, which is why the study measures the effect on the pharmacokinetics of bi 1584862.

  4. Step 4

    Final evaluation

    A concluding health check is performed to ensure you have returned to your normal condition.

    The study data are reviewed, and you are informed that your participation in the trial is complete.

Who can join the trial?

4 criteria

  • Be a healthy male volunteer, as confirmed by the doctor after a complete medical history, a physical exam, checks of vital signs (including blood pressure and pulse rate), a 12‑lead ECG (a heart test), and routine laboratory tests.
  • Be between 18 and 50 years old, inclusive.
  • Have a body mass index (BMI) between 18.5 and 29.9 kg/m² (a measurement that compares weight to height).
  • Sign and date a written informed consent form that follows ICH‑GCP (International Council for Harmonisation Good Clinical Practice) guidelines and local laws, before joining the study.

Who cannot join the trial?

5 criteria

  • Any result from the medical exam (including blood pressure, pulse rate or ECG test) that is not normal and the doctor thinks is important.
  • Repeated measurements showing systolic blood pressure lower than 90 mmHg or higher than 140 mmHg, diastolic blood pressure lower than 50 mmHg or higher than 90 mmHg, or a pulse rate lower than 45 beats per minute or higher than 90 beats per minute.
  • Any lab test result that is outside the normal range and the doctor considers it clinically relevant.
  • Any other disease or health condition that the doctor judges to be important for the study.
  • Other reasons not listed here may also prevent participation.
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 1584862

    is an experimental medication being tested in this study. Participants take a single oral tablet of this drug, and researchers measure how it is absorbed, distributed, and cleared from the body. The goal is to understand the basic behavior of BI 1584862 in healthy people before it can be studied for any specific disease.

  • itraconazole

    (sold as Sempera Liquid) is a medication that blocks the activity of an enzyme called CYP3A4, which is important for breaking down many drugs in the body. In this trial, itraconazole is given to see how strongly stopping the enzyme affects the way BI 1584862 is processed. By comparing the drug’s behavior with and without itraconazole, researchers can learn whether BI 1584862 might need dose adjustments when taken with other medicines that affect CYP3A4.

What is already known about the treatment

  • BI 1584862

    This investigational drug is taken by mouth as a film‑coated tablet containing 20 mg of the active substance. It is currently in early clinical testing and has not yet been approved for any medical use. The trial is exploring its potential therapeutic role, which is still being defined, and it is thought to be a small‑molecule compound that is processed by the liver enzyme CYP3A4. Pharmacologically, it is classified as an experimental oral small‑molecule agent and a likely CYP3A4 substrate.

  • Itraconazole

    Itraconazole is administered orally as a liquid solution (10 mg/ml) with a typical dose of 200 mg. It is an approved antifungal medication that is widely used to treat various fungal infections such as aspergillosis, blastomycosis, and onychomycosis. The drug works by blocking a fungal enzyme called lanosterol 14α‑demethylase, which stops the fungus from making its essential cell membrane component ergosterol. It belongs to the azole class of antifungal agents and is also known as a strong inhibitor of the liver enzyme CYP3A4.

Investigated diseases

Conditions this trial is registered against

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-503542-31-00Protocol code1484-0003Estimated enrolment14 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.