• 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 in 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.
• On the day of the administration, you will swallow a capsule on a thread to collect fluid from your small intestine. The upper part of the thread will be attached to your cheek. The capsule and the lower part of the thread are carried by the action of the stomach into the small intestine. The capsule dissolves releasing the thread. The lower part of the thread remains there to absorb bile and intestinal fluid and will be removed approximately 4.5 hours after you have swallowed the capsule.

• You are a healthy male.
• You are at least 18 and at most 55 years old.
• Your weight is at least 60 kg and your Body Mass Index (BMI) is at least 18.0 and at most 29.9 kg/m2. 
• Both non-smokers and light smokers (maximum of 5 cigarettes per day for 1 month prior to dosing) are allowed to participate in this clinical trial. During your 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 3 months prior to the screening 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. Microdose studies have a negligible amount of radiation burden (lower or equal to 0.1 mSv), 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 with every sexual contact;
  • You are not sexually active according to your lifestyle.

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for at least 12 days (11 nights) and at most 16 days (15 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 16 days, you have to come back to the research facility weekly for a maximum of 4 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 on the day of your last departure from our research facility.

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