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.



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