Study of BI 1810631 (C‑14) oral solution, BI 1810631 (C‑14) IV microtracer, and BI 1810631 tablet to assess absorption and metabolism in healthy men

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What is this study about?

The investigation involves a new compound called BI 1810631 that is being tested in healthy adult men. The compound is given in three ways: as a liquid taken by mouth called an oral solution, as a small pill known as a film-coated tablet, and as a very small dose injected into a vein, referred to as an intravenous microtracer. The liquid and the injected dose contain a tiny amount of a radioactive marker labeled C-14 to help track the drug inside the body.

The aim of the study is to understand how the body takes up, breaks down, and removes the drug, including how much of it reaches the bloodstream and how much is eliminated in waste. In the first part, participants receive the oral solution and provide samples of urine and feces over several days. In the second part, participants take the tablet while a microtracer dose is given by injection, and blood is drawn to measure the drug in plasma.

Researchers will calculate the total amount of drug recovered (mass balance), study its metabolism and overall movement through the body (pharmacokinetics), and determine the absolute bioavailability of the tablet form. The analysis includes measuring the overall exposure (AUC) and the highest concentration reached (Cmax) in the blood.

Who Can Join the Study?

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Pecokuztfyxccc Rviboles Aqehuizxos Gzstq Boqi Groningen The Netherlands

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

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
16.08.2023

Trial locations

Investigated drugs:

Trial ID:
2022-503047-17-00
Protocol code:
1479-0006
Trial Phase:
Human Pharmacology (Phase I) – Other

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