In short
BI 764198 XX (C-14) is an investigational substance developed by Boehringer Ingelheim International. It is a mixture given as an oral solution and is being studied in cardiovascular diseases. The only registered trial so far is a completed Phase 1 study in 16 healthy men that investigated how the substance is processed in the body.
Key points
- BI 764198 XX (C-14) is an investigational substance with no marketing authorisation.
- It is being developed in the therapeutic area of cardiovascular diseases.
- The only registered trial is a Phase 1 study in 16 healthy men.
- The trial is completed and investigated how the substance is absorbed, broken down and excreted.
- The substance is given as an oral solution.
- The trial used a 40 mg dose with a radiolabelled tracer.
What is BI 764198 XX (C-14)?
BI 764198 XX (C-14) is an investigational substance developed by Boehringer Ingelheim International. It has no marketing authorisation in the product records, which means it is not an approved medicine and is still being studied in clinical trials. The substance is classified as a mixture and is being developed in the therapeutic area of cardiovascular diseases.
How does BI 764198 XX (C-14) work?
The registered trial data do not describe the mechanism of action of BI 764198 XX (C-14). The Phase 1 study focused on how the body processes the substance rather than on its biological effects. The trial used a radiolabelled form of the substance, with carbon-14 (C-14) incorporated into the molecule, to track its path through the body.
Which conditions is BI 764198 XX (C-14) studied for?
- Healthy volunteers: the only registered trial enrolled healthy men to study how the substance is absorbed, broken down and excreted, not to treat a disease.
- Cardiovascular diseases: the substance is registered in the cardiovascular disease therapeutic area, which indicates the intended field of future research, although no patient trials are registered yet.
How is BI 764198 XX (C-14) given?
BI 764198 XX (C-14) is prepared as an oral solution and is given by oral use, meaning it is swallowed as a liquid. In the registered trial, a 40 mg dose was given orally.
What do the clinical trials show?
Only one clinical trial of BI 764198 XX (C-14) is registered. It is a Phase 1 study that enrolled 16 healthy men and has been completed. The main objective was to investigate the basic pharmacokinetics of the substance and its metabolites, including mass balance, excretion pathways and metabolism, using a classical hADME approach and a microtracer approach.
The primary outcomes measured were the mass balance recoveries of total radioactivity in urine and faeces. Specifically, the trial measured the fraction of carbon-14 radioactivity excreted in urine and in faeces, each expressed as a percentage of the administered dose over the time interval from 0 to the last quantifiable time point. These measurements help researchers understand how much of the substance leaves the body through each route and over what time period.
The trial also included a comparison arm with another substance, [4-(6-aminopyridazin-3-yl)piperidin-1-yl][5-(4-fluorophenoxy)-4-methoxypyridin-2-yl]methanone, also given as a 40 mg oral dose.
What side effects are known?
No information on side effects is available from the registered trial data or the supplementary sources provided.