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

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What is this study about?

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.

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 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 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 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 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 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 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 second medication administration

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

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 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 Study?

  • 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)</b) between 18.5 and 29.9 kg/m², which is a measure that compares your weight to your height to see if you are in a normal weight range.
  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cob Cyblacml Rukswcyi Snfhesmh Mepxzackns Gooa Berlin 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
26.10.2023

Trial locations

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.

Trial ID:
2022-502860-19-00
Protocol code:
1479-0010
Trial Phase:
Human Pharmacology (Phase I) – Other

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