The study compound is a new compound that may potentially be used for the treatment of primary sclerosing cholangitis (PSC). This is a chronic (never completely healing again) liver disease that damages the bile ducts and liver. Bile is a digestive liquid that is made in the liver and travels through the bile ducts to the gallbladder and the small intestine, where it helps digest fats and vitamins. In patients with PSC, the bile ducts become blocked due to inflammation and scar tissue

This is a clinical trial with a radioactive (Carbon 14, ¹⁴C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and how much of the compound is absorbed, distributed, 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 one 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.

The study compound has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals. In previous studies of the study compound in both healthy participants and participants with PSC, the study compound has been generally well-tolerated. Side effects you might experience when using it are: diarrhea, abdominal pain or discomfort, headache, dizziness and influenza-like illness. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which 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.
• 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 30.0 kg/m2. 
• You do not smoke and you have not used any nicotine-containing products in the 6 months prior to the screening.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the dosing 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 condition does not apply for microdose (¹⁴C) studies. These trials have a negligible amount of radiation burden, please contact us for more information and to see if this is applicable for 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.
• 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 fertile female partner (like the pill or intrauterine device);
  • You have been sterilized or 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 sexually active with a partner of the same sex and you use a condom.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for at least 9 days (8 nights) and at most 11 days (10 nights). The exact length of your stay is dependent on the amount of radioactivity in your body. If the amount of radioactivity is not low enough after 11 days, you have to come back to the research facility for a maximum of 2 times for a 24-hour visit (1 night stay per 24-hour visit), until the radioactivity is low enough. The follow-up will take place 5 – 9 days after your last departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.