• The new study compound is being developed to treat inflammatory diseases. These conditions arise because the (dysregulated) immune system reacts for too long or too intensely. This leads to unnecessary, prolonged inflammation accompanied by swelling and pain.
• You will receive a single dose of the study compound. This will be administered as capsules that you swallow.
• This is a clinical trial with a radioactively (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 with the compound through the faeces, urine and/or breath. The compound has a negligible amount of radiation burden. Please contact us for more information.
• The compound has already been tested in healthy individuals and patients. In these clinical trials, the compound was considered safe and well tolerated. The following side-effects were observed most often: headache and diarrhea. 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 the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether 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 55 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.5 kg/m². 
• Non-smokers and smokers who smoke no more than 10 cigarettes per day are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

• You can only participate if you meet one of the following conditions:
  • You use a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 1 month prior to the compound administration in this clinical trial (counting from the last follow-up visit of the previous clinical trial). For some trials, this period could be longer, please contact us for more information to see if this applies to you.
• You can only participate in this trial if you have not participated in another trial with a radioactive (¹⁴C) labeled compound in the past 12 months. For some trials with radioactive compounds, this period could be shorter, please contact us for more information to see if this applies to you.
• To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 16 days (15 nights). This will be followed by one 24-hour visit 7 days after your departure.
If not enough radioactivity has cleared your body after this visit, there will be one to six additional 24-hour visits.

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.