The immune system normally serves as the body's first line of defense against illness and poor health. Sometimes, however, the immune system does not function properly, causing the body to lose its natural defenses or even attack its own tissues. In such cases, we speak of autoimmune diseases. 

• This is a trial with a radioactive (¹⁴C) labeled compound.
• In this trial, participants take a tablet containing the study drug once by mouth. They also receive a small dose containing a negligible amount of radioactivity through a vein. Radioactive labeling allows to discriminate the study compound coming from the tablet and from the injection. This helps us understand how much of the compound is taken up into the body when taken by mouth. The radioactivity disappears from the body at the same time as the compound. The radiation burden is negligible because the amount of radioactively labelled compound is very low.
• The compound has already been tested in healthy individuals and patients with an autoimmune disorder. The following side-effects were observed most often in trials with multiple administrations: headache, throat infection or throat pain, urinary tract infection, diarrhea, stomach pain, joint stiffness, muscle pain, oral herpes (cold sores or painful, itchy blisters or ulcers in or around the mouth) and dry eyes. 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 before the start of the medical screening. You can ask questions to the screening physician or nurse at that stage. 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 why you no longer wish to participate.

• You are a healthy male.
• You are at least 18 and at most 65 years old at the time of screening.
• Your Body Mass Index (BMI) is at least 18.0 and at most 29.9 kg/m² at the time of screening. The BMI shows the relationship between body weight in kilograms and height in meters.
• Both non-smokers and smokers are allowed to participate in this clinical trial. You are not allowed to smoke within 48 hours prior to admission and during your stay in our research facility, so up to 6 days in total.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the screening for this clinical trial (counting from the follow-up visit of the previous study).
• 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. This timeframe is shorter for studies involving very low doses of radioactivity . Please contact us 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.
• There are no contraceptive requirements for males.

Before the trial starts, you will undergo a medical screening during one visit to see if you are eligible.

The trial itself consists of 1 period during which you will stay in the research facility in Groningen for 4 days (3 nights), followed by 10 short visits. The last short visit will be the follow-up visit. A follow-up telephone call will take place 30 to 40 days after the last short visit.

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