In short
BI 1810631 (C-14) is an investigational, chemically synthesised substance supplied by Boehringer Ingelheim International. It is a radiolabelled form of zongertinib (BI 1810631), a kinase inhibitor that selectively targets human epidermal growth factor receptor 2 (HER2). One completed Phase 1 trial in 15 healthy men investigated how the body takes up, processes and excretes the substance.
Key points
- Phase 1 study completed in 15 healthy men.
- Tested oral and intravenous forms of BI 1810631 (C-14).
- Main goals: mass balance, total recovery of radioactivity, and absolute bioavailability.
- Study status: Completed.
- Substance is an investigational medicine with no marketing authorisation.
- BI 1810631 is also known as zongertinib, a HER2 kinase inhibitor.
What is BI 1810631 (C-14)?
BI 1810631 (C-14) is a chemically synthesised, investigational substance. It is a radiolabelled form of BI 1810631, which is also known as zongertinib. The product records of the trial show no marketing authorisation, meaning it is not yet an approved medicine. The substance is supplied by Boehringer Ingelheim International.
How does BI 1810631 work?
Zongertinib is a kinase inhibitor that selectively inhibits human epidermal growth factor receptor 2 (HER2). In laboratory studies, it inhibited phosphorylation of HER2 and downstream signalling. HER2 is a protein that can drive cell growth when overactive, particularly in some cancers. By blocking HER2, the substance aims to interrupt signals that promote uncontrolled cell division.
Which conditions is it used or studied for?
- Healthy volunteers — the only registered trial was conducted in healthy men to learn how the body handles the substance, not to treat a disease.
Because BI 1810631 targets HER2, it may be of interest for conditions where HER2 plays a role, but no registered trials in patients are listed in the provided data.
How is BI 1810631 given?
The trial used three forms: an oral solution containing BI 1810631 (C-14), a solution for infusion given intravenously as a microtracer, and a film-coated tablet of non-radiolabelled BI 1810631. The oral dose tested was 60 mg; the intravenous dose was 100 micrograms.
What do the clinical trials show?
One Phase 1 trial (EU CT number 2022-503047-17-00) enrolled 15 healthy men and is completed. The study had two parts. Part A measured the mass balance and total recovery of radioactivity in urine and faeces after a single oral dose of the radiolabelled substance. Part B investigated the absolute bioavailability of the film-coated tablet compared with the intravenous microtracer by measuring the area under the concentration-time curve (AUC), which reflects how much drug reaches the bloodstream over time.
What side effects are known?
No side effect data are provided in the available sources.