This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted by the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. The compound has a radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in 2 to 3 months. This background radiation is released from space, soil, air, water, food and construction materials. To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.
The compound has already been tested in healthy individuals and is being tested in patients with a type of blood vascular malformation in an ongoing study. In these studies, the following side-effects were observed most often: headache, fatigue, and skin rash. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the study, which also describes the possible side effects. This information will also be discussed with you during the medical screening. You can then ask questions to the screening physician or nurse. The medical screening will only take place after you have given written consent to participate in the study. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. You do not need to provide a reason for why you no longer wish to participate.