• In autoimmune diseases, the immune system does not function properly and attacks the body’s own tissues. This can lead to inflammation and damage. Examples include systemic sclerosis (a disease in which the skin and organs become hardened) and lupus (a disease that causes inflammation in various organs).
• This trial consists of 2 parts, part A and part B. You can only participate in one part.
• For Part A and B: 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 negligible amount of radiation burden. Please contact us for more information.
• Only for part A: To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial. You will receive a single dose of the study compound. This will be administered in the form of a cloudy drink.
• Only for part B: You will receive a single dose of the study compound. This will be administered in the form of tablets to swallow together with a solution of the compound that is injected directly into a blood vessel. 
• The compound has already been tested in healthy individuals. No side-effects specific to the study compound have been identified in previous studies. You may 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 55 years old.
• Your Body Mass Index (BMI) is at least 18.5 and at most 30.0 kg/m2. 
• Both non-smokers or light smokers (maximum of 5 cigarettes or 5 vaping sessions or 1 cigar or 1 pipe per day) are allowed to participate in this clinical trial. During your 7 or 8-day stay in our research facility you are not allowed to smoke.

​Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the first compound administration in this clinical trial (counting from the last dosing).
• 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 restriction does not apply to studies using a very low dose of radioactivity (so-called 14C microdose studies). These studies have a negligible amount of radiation burden, please contact us for more information and 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.

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

The trial consists of 2 parts: part A and part B.

Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). If not enough radioactivity has left your body after 6 days, there will be one or two more 24-hour visits. The follow-up visit will take place within 7 days after your final departure from the research facility. If one 24-hour visit is needed, the follow-up visit will take place within 7 days after your departure from the research facility. If both 24-hour visits are needed, the follow-up visit will take place on the day of your final departure from the research facility.

Part B: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up visit will take place within 7 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.