• The study compound is being developed for the treatment of diseases in which the immune system attacks the body’s own tissues. These are called autoimmune and inflammatory diseases. Such diseases often cause inflammation, for example in the skin or joints. Examples include psoriasis (a skin condition with red, scaly patches) and psoriatic arthritis (an inflammatory disease-causing pain and swelling in the joints).
• In this clinical trial, we will investigate how well different formulations of the study compound are absorbed by the body, and how food affects this, after taking a single dose.
• The study consists of two parts: Part 1 and Part 2. You will participate in both parts.
• The study compound will be administered as a tablet (by mouth). You will receive the study compound a total of four times in four different study periods. The study compound has been administered to people before.
• During part 2 you will receive a high-fat high-calorie breakfast before you receive the study compound. The high-fat high-calorie breakfast has a standard composition, which you must start exactly on time and finish within 30 minutes. The entire breakfast must be consumed. The high-fat high-calorie breakfast is a large breakfast, which includes 2 fried eggs, fried potatoes and bacon or cheese. It might be difficult for light eaters to consume the entire breakfast.
• During each stay period, one COVID test will be taken upon arrival.
• It may be decided that an additional group will be added who only need to complete the last period (part 2).

The compound has already been tested in healthy individuals. In these clinical trials, the following potential side-effects were observed: infections, allergic reactions, suicidal thoughts or behavior, decreased blood pressure, intestinal inflammation (for example: diarrhea, abdominal pain, cramping or bloating), headache or dizziness. 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 or female.
• You are at least 18 and at most 60 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18 and at most 30 kg/m2. 
• You do not smoke and do not use any nicotine-containing products (not for at least 6 months prior to screening).

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom in combination with an additional contraception method used by your female partner, and you are willing to continue using this dual contraception for up to 3 months after the last dose of the study compound;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

Note:

• You cannot participate in the trial if you have participated in another clinical trial during the 56 days prior to the first compound administration in this clinical trial (counting from the last dosing in the previous trial). For some clinical 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 4 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by one short visit after period 3 and period 4.

If it is decided that an additional group will be added, this part of the trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 7 to 11 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