• The study compound is being developed as a treatment for controlling weight in adults with obesity, a condition in which excessive fat accumulates in the body, which can lead to health risks.
• 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, and urine. In this study a radioactive microdose will be used that has a negligible radiation burden. To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.
• This study consists of 2 periods. In period 1 you will receive the compound once via the mouth as a drink. In period 2 you will receive the compound once via the mouth as a drink, and once via an intravenous infusion (liquid form of the compound administered directly in a vein in your arm). In period 1 the drink is radioactively labeled, in period 2 only the intravenous infusion is radioactively labeled.

The compound has already been tested in healthy individuals and people with obesity. Side effects that were observed most often in these clinical trials were skin rashes and headaches. In general, these side effects were mild. 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.
• You are at least 18 and at most 65 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 17.5 and at most 32.0 kg/m2. 
• You don’t smoke or you smoke a maximum of 5 cigarettes per day. During your stay in our research facility you are not allowed to smoke.
• You don’t drink or you drink a maximum of 14 units of alcohol per week.
• 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;
  • You are using a condom and 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 using a condom and 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 in the 30 days prior to the first compound administration in this clinical trial (counting from the last compound administration in the last clinical trial).
• 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. For microdose studies this timeframe is shorter, please contact us 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. This will be performed in Groningen.

The trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). During period 1 you will stay for at least 9 days (8 nights), and at most 22 days (21 nights). During period 2 you will stay for 9 days (8 nights). When you can leave the research facility after period 1 will be based on your lab values. If you have to stay for the maximum number of days, you will stay at the research facility from the start of period 1 until the end of period 2 which will be 30 days (29 nights) in total. The follow-up will be via a phone call.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.