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

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What is this study about?

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.

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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Site Name City Country Status
Bleellxwlj Ijyswuznw Posxay Gmra &xvxg Cxp Ky Biberach Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
29.09.2023

Trial locations

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.

Trial ID:
2023-503542-31-00
Protocol code:
1484-0003
Trial Phase:
Human Pharmacology (Phase I) – Other

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