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Effect of carbamazepine on the blood levels of BI 1810631 after a single dose in healthy men

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What is this study about?

The investigation involves healthy male volunteers, so no disease is being treated. It examines whether the medicine carbamazepine, a drug commonly used for seizure control that can speed up the activity of certain body enzymes, influences the amount of a new experimental compound called BI 1810631 that appears in the blood. The purpose is to determine if carbamazepine changes the pharmacokinetics – that is, how the body absorbs, distributes, and clears the new drug.

Participants will first take carbamazepine tablets for several days, then receive a single dose of the experimental drug. Blood samples will be collected at several times after the dose to measure the drug level. After a short break, the same participants will receive the experimental drug alone, with another series of blood samples taken. The study compares the drug amounts with and without carbamazepine to see if the enzyme‑activating effect of carbamazepine, known as CYP3A induction, alters the blood concentration of the new medication.

1 baseline assessment

you will attend an initial visit where health information is recorded and basic laboratory tests are performed to confirm eligibility.

this visit marks the start of your participation in the study.

2 first study period – single dose of <b>BI 1810631</b>

you will receive one oral tablet containing 60 mg of BI 1810631 (film‑coated tablet).

the tablet is taken once, with water, under supervision of the study staff.

blood samples will be collected at several time points after the dose to measure the amount of drug in your plasma.

3 second study period – multiple doses of <b>carbamazepine</b> followed by a single dose of <b>BI 1810631</b>

you will take oral carbamazepine tablets each day for a number of days as specified by the study protocol.

the tablets are either 600 mg or 400 mg prolonged‑release tablets (designed to release the medicine slowly over time).

after the series of carbamazepine doses, you will receive another single oral tablet of BI 1810631 (60 mg, film‑coated).

as in the first period, blood samples will be drawn at multiple time points after this dose to assess how the carbamazepine treatment influences the level of BI 1810631 in your blood.

4 final follow‑up

after the last blood sample, you will have a final visit during which any remaining study procedures are completed and a safety check is performed.

you will be thanked for your contribution and given information about the study’s completion.

Who Can Join the Study?

  • Be a male who is in good health, confirmed by the doctor through a medical history, physical exam, checks of vital signs such as blood pressure (BP) and pulse rate (PR), a heart test called a 12‑lead ECG, and routine lab tests.
  • Be between 18 and 55 years old, including the ages at the ends of the range.
  • Have a body mass index (BMI) between 18.5 and 29.9 kilograms per square meter, which is a standard measure of weight relative to height.
  • Provide a signed and dated written informed consent form, showing you understand the study and agree to take part, as required by international guidelines and local laws.

Who Cannot Join the Study?

  • If any part of the medical exam—such as blood pressure, the heart‑electric test (ECG), nerve check, or skin inspection—shows an abnormal result that the doctor thinks is important.
  • If repeated checks show a systolic blood pressure (the top number) lower than 90 mmHg or higher than 140 mmHg, a diastolic blood pressure (the bottom number) lower than 50 mmHg or higher than 90 mmHg, or a pulse rate (heart beats per minute) lower than 50 bpm or higher than 90 bpm.
  • If any laboratory value (such as blood or urine test results) is outside the normal range and the doctor believes it matters for the study.
  • If there is any other health condition (concomitant disease) that the doctor assesses as important for the study.
  • If any additional exclusion reasons apply that are not listed here.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Cyd Cqhmposq Rihihzoo Srrhfgfq Mdyzgfwu Gnaf Mannheim 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
12.09.2023

Trial locations

Investigated Drugs:

BI 1810631 is an experimental medicine being studied for the first time in people. In this trial participants take a single oral tablet of BI 1810631, and researchers measure how the drug is absorbed, distributed, and cleared from the body. The purpose is to understand its behavior in the bloodstream when no other medicines are affecting it.

carbamazepine is a medication that is known to increase the activity of an enzyme called CYP3A, which helps the body process many drugs. In this study, healthy volunteers take carbamazepine repeatedly over several days. The researchers then give a single dose of BI 1810631 to see how carbamazepine changes the way BI 1810631 is handled by the body. This helps determine whether carbamazepine could affect the effectiveness or safety of BI 1810631 when both are used together.

Trial ID:
2022-503046-50-00
Protocol code:
1479-0011
Trial Phase:
Human Pharmacology (Phase I) – Other

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