• The study compound is a new compound that may potentially be used for the treatment of inflammatory diseases. Certain types of inflammatory diseases can be caused by having too many immune cells at the sites of inflammation. The compound is being developed to prevent the immune cells from moving to the sites of inflammation and could therefore in the future potentially be useful for the treatment of inflammatory diseases.
• The trial consists of 2 groups. You can only participate once.
  • In group 1, you will receive the study compound twice as a drink and once as an intravenous (in the vein) infusion.
  • In group 2, you will receive the study compound once as a drink.
• 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 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 1 month. 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. The trial where the study compound was given to humans (healthy subjects) for the first time, was completed. The safety of the study compound was assessed, and no new important potential risks for the study compound were found based on the data from this study. A trial conducted in a specific group of patients is ongoing, and as of 12 December 2023, there has been no emerging safety concern. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

• You are a healthy male.
• You are at least 18 and at most 65 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 17.5 and at most 32.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 5 cigarettes per day on average). During your stay in our research facility, you are not allowed to smoke.
• There are no contraception requirements for this trial.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the last compound administration).
• To determine if you are suitable to participate in this trial, you will undergo a medical screening in Groningen. 

Group 1: the trial consists of 2 periods during which you will stay for at least 8 days (7 nights), and at most 15 days (14 nights) in the research facility in Groningen (location van Swietenlaan 6). How long you must stay depends on the amount of radioactivity that you still have in your body. If you must stay the maximum number of days in period 1, you will not go home between the periods and period 2 will run directly after period 1. In that case, the stay is 22 days (21 nights). A follow-up by phone will take place 14 to 28 days after your departure from the research facility.

Group 2: the trial consists of 1 during which you will stay for at least 8 days (7 nights), and at most 15 days (14 nights) in the research facility in Groningen (location van Swietenlaan 6). How long you must stay depends on the amount of radioactivity that you still have in your body. A follow-up by phone will take place 14 to 28 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.