• The study compound is being developed for the treatment of inflammatory diseases. The study compound may help reduce inflammation in the body. Inflammation is the body’s response to things like injury or illness, such as redness, swelling, pain, or fever.
• In this clinical trial, we are investigating how the study compound is processed and eliminated by the body. We will investigate how well it is tolerated when it is used by healthy participants. We also investigate whether your hereditary characteristics have an effect on how your body reacts to the compound. This part of the trial is not mandatory.
• The study compound will be administered once as a capsule (by mouth) with 240 mL of water.
• 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 amount of radiation from the compound is low. It is about the same as the natural background radiation you are normally exposed to in the Netherlands over 2 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.

• 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 29.9 kg/m². 
• You do not smoke and you have not used any nicotine-containing products in the 3 months prior to the start of the trial
• You can only participate if you meet one of the following conditions during the trial and for up to 90 days after the last dose:
  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You use a condom and you have been sterilized or your female partner is sterilized or has passed menopause (no periods for at least 12 months);
  • You use a condom with your pregnant partner;
  • You are using a condom with your male partner;
  • 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 3 months prior to admission in this clinical trial (counting from the last dosing in the previous trial).
• 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 this period could be longer. Please contact us for more information.
• 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 for 18 days (17 nights).
Depending on the amount of radioactivity that remains in your body, 1 to 4 24-hour visits will follow (1 overnight stay per 24-hour visit).

The follow-up visit will take place 5 to 10 days after your last departure from the research facility. If your follow-up visit has already taken place 5 to 10 days after your stay in the research facility, you will receive a follow-up call 14 days after your departure from the research facility for some questions.

Note: You must be available for all dates to be able to participate in this clinical trial. The location in Groningen is Van Swietenlaan 6.