The study compound is being developed for the treatment of type 2 diabetes and weight control. It lowers blood sugar levels. People with type 2 diabetes have too much sugar in their blood. They need treatment to control their blood sugar levels. The study compound acts like a hormone that occurs naturally in the body. This hormone helps people feel full and helps to lower blood sugar levels. Some medications that act this way are already approved. They are being used to treat people living with diabetes and for weight control. These medications are generally administered with an injection under the skin. The study compound is administered orally, which will ultimately be much easier for the patient.

In this trial, you will receive the study compound as a capsule via the mouth with 240 milliliters of water. Six hours later, you will receive a solution of the study compound administered directly into a blood vessel via an intravenous infusion.

This is a clinical trial with a radioactively (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 radiation burden which is less than that from the natural background radiation that you are exposed to in the Netherlands in 1 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 compound has already been tested in healthy individuals and patients with type 2 diabetes. In these clinical trials, the following side-effects were observed most often: nausea, vomiting and diarrhea. In general, these side effects were not considered severe. 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 the screening physician or nurse any questions you may have. Once everything is clear to you, you can then decide whether or not 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 to stop participating in 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 Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• Both non-smokers and light smokers or occasional smokers (max. 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
   
• 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 use a condom and your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You use a condom and you have been sterilized;
  • You use a condom and you are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous trial). This may be longer in certain trials, so please contact us for more information.
• 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 timeframe is longer for clinical trials involving higher doses of radioactivity . Please contact us 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.

The trial consists of 1 period during which you will stay in the research facility in Groningen for at least 10 days (9 nights) and at most 14 days (13 nights). Depending on the radioactivity levels in your body at the end of the stay, you may have to return to the research facility for one 24-hour visit. The follow-up visit will take place 25 to 31 days after the start of the clinical trial.

Note: You must be available for all dates to be able to participate in this clinical trial. The location is Van Swietenlaan 6 in Groningen.