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.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

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Other Sites

Site Name City Country Status
Bctqbhfapw Iogkjqnaw Pczxrj Gyxn &cedf Crd Kf 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
25.07.2023

Trial locations

Trial ID:
2022-502424-43-00
Protocol code:
1509-0001
Trial Phase:
Human Pharmacology (Phase I) – First administration to humans

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