Safety, tolerability, pharmacokinetics and food effect of BI 3000202 in healthy adult men: a randomised placebo‑controlled single‑dose study

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What is this study about?

The study examines how a new oral medication, BI 3000202, behaves in the bodies of healthy adult men. No specific disease is being treated; participants are volunteers without a related medical condition.

The purpose is to evaluate safety, tolerability, and the way the drug moves through the body (pharmacokinetics) at increasing dose levels, and to compare the amount of drug that reaches the bloodstream when taken with food versus on an empty stomach (bioavailability). Participants receive a single dose of either the study drug at one of several strengths (3 mg, 10 mg, 25 mg, or 250 mg) or a placebo in a blinded fashion, followed by blood sampling over 24 hours. In a separate part, the same participants take the drug as a tablet once with a standard meal and once without food, and blood is drawn to measure the drug concentration.

Safety checks include monitoring for any side effects that may be related to the medication, and blood tests are used to calculate measures such as the AUC (total exposure of the drug in the blood) and the highest concentration reached. The study lasts for a short period after each dose, with participants returning for follow‑up visits as needed.

1 initial visit and baseline assessments

after you join the study, you will attend an initial visit where you will sign the consent form and undergo basic health checks such as vital signs, blood tests, and a physical examination.

the purpose of these assessments is to confirm that you meet the criteria for a healthy volunteer and to record your baseline measurements before any medication is taken.

2 randomisation and first single dose

you will be randomly assigned to receive either an active tablet of bi 3000202 at a dose of 3 mg or a matching placebo tablet that contains no active ingredient.

the tablet is taken orally with a glass of water, and it is a one‑time administration on the scheduled dosing day.

3 post‑dose observation and blood sampling

after taking the tablet, you will remain at the study site for a monitoring period during which staff will check you for any adverse events (side effects).

blood samples will be collected at several time points over the next 24 hours to measure the amount of drug in your bloodstream and to assess safety.

4 washout period before next dose

a washout period, during which no study medication is taken, will follow each dosing day to allow the previous dose to leave your body completely before the next dose is given.

5 subsequent single doses with increasing amounts

you will repeat the same procedure for three higher dose levels: 10 mg, 25 mg, and 250 mg of bi 3000202.

each dose is taken as a single oral tablet, followed by the same 24‑hour blood‑sampling and safety monitoring as described for the first dose.

6 food effect part – fasting condition

after completing the rising‑dose series, you will enter the food‑effect portion of the study.

on the first food‑effect visit, you will fast for at least 10 hours (no food or drink except water) before taking a single 250 mg tablet of bi 3000202.

blood samples will again be taken over the next 24 hours to evaluate how the drug is absorbed when taken on an empty stomach.

7 food effect part – fed condition

after another washout period, you will return for the second food‑effect visit.

this time you will eat a standard high‑fat meal and, within 30 minutes after starting the meal, take another single 250 mg tablet of bi 3000202.

the same 24‑hour blood‑sampling schedule will be used to compare drug absorption with food versus without food, which is called bioavailability.

8 final assessments and study completion

once all dosing visits are finished, you will undergo final safety checks, including a last set of vital signs and blood tests.

the study staff will review the information collected during the trial and then you will be discharged from the study.

Who Can Join the Study?

Healthy male subjects as judged by the study doctor after a full medical history, a physical check‑up, measurement of vital signs (such as blood pressure and pulse rate), a 12‑lead ECG (a test that records the heart’s electrical activity), and lab tests, with no important health problems found.
Age between 18 and 45 years, inclusive.
Body mass index (BMI) from 18.5 to 29.9 kg/m². BMI is a simple calculation that compares weight to height to see if a person is underweight, normal weight, or overweight.
Signed and dated written informed consent following ICH‑GCP (International Council for Harmonisation Good Clinical Practice, which ensures the study is done safely and ethically) and local laws, completed before entering the trial.

Who Cannot Join the Study?

Abnormal medical exam results – If any part of the physical check‑up (including blood pressure (BP), pulse rate (PR), or an electrocardiogram (ECG) that records the heart’s electrical activity) is outside the normal range and the doctor believes it is important, you cannot take part.
Blood pressure or pulse rate outside set limits – If repeated measurements 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, you are excluded.
Laboratory test results outside normal ranges – Any blood, urine or other lab test that falls outside the standard reference values and the investigator judges to be important will prevent participation.
Presence of another health condition – If you have any additional disease or health problem that the investigator considers relevant, you cannot join the study.
There may be additional exclusion reasons not listed here that could also prevent participation.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Bmvtxecbcu Ijwumonex Pwhaig Gccb &skzi Crm Ki	Biberach	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	25.07.2023

Trial locations

BI 3000202 is an experimental oral tablet being tested in healthy volunteers. In the study, participants take a single dose of the tablet to see how safe it is, how well people tolerate it, and how the body absorbs and processes the medicine. The trial also compares how much of the drug gets into the bloodstream when taken with food versus on an empty stomach, helping researchers understand if meals affect its effectiveness. This information will guide future studies and potential use of the medicine.

Trial ID:

2022-502424-43-00

Protocol code:

1509-0001

Trial Phase:

Human Pharmacology (Phase I) – First administration to humans

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Safety, tolerability, pharmacokinetics and food effect of BI 3000202 in healthy adult men: a randomised placebo‑controlled single‑dose study

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?