• The study compound is a new compound that may potentially be used for the treatment of (severe) allergic diseases. Hopefully, it will reduce inflammation associated with these types of conditions.
• The study compound has been administered to humans before. In addition, it has been tested in the laboratory and on animals.
• The trial consists of two groups. You may participate in only one group. You will receive the study drug as follows:
• Group 1: On day 1 of the study once as tablets via the mouth, followed by an injection, and on day 8 once as a drink.
• Group 2: On day 1 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 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 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.

• You are a healthy male.
• You are at least 18 and at most 55 years old.
• Your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m². 
• Before the start of the study, you have not smoked or used nicotine-containing products for at least 3 months.
• 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 fertile female partner from admission until 90 days after the last dosing.
  • You have been sterilized or your female partner is sterilized or has passed menopause (no periods for at least 12 months);
  • You are only sexually active with a same-sex 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 30 days prior to the first entry in this clinical trial (counting from the last dosing of the previous trial). This may be longer for certain trials, please contact us for more information.
• 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. If you have previously participated in a microdose study (a very low dose of a radioactive substance), you can participate.
• 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.

Group 1
The trial consists of 1 period during which you will stay in the research facility in Groningen for 22 days (21 nights). The length of your stay depends on the level of radioactivity in your body, if it is low enough, you may be able to leave earlier. Finally, there is a short visit for the follow-up.

Group 2 
The trial consists of 1 period during which you will stay in the research facility in Groningen for 15 days (14 nights). The length of your stay depends on the level of radioactivity in your body, if it is low enough, you may be able to leave earlier. Finally, there is a short visit for the follow-up.

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.