• The study compound could potentially be used for the treatment of mood and anxiety disorders. Mood and anxiety disorders are mental health conditions that affect a person's emotional state and how they cope with stress and anxiety. They can significantly impact daily functioning, relationships, and overall well-being. Mood disorders primarily involve disturbances in a person’s emotional state or mood. They often involve prolonged periods of excessive sadness, elevated mood, or a combination of both. Anxiety disorders involve excessive fear or anxiety that is difficult to control and that interferes with daily activities. 
• This is a clinical trial with a radioactive (14C) labeled compound. Radioactive 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. In this study a very small radioactive dose will be used which has a negligible radiation burden. 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. In these studies, nausea and dizziness were the most commonly observed side effects. You may also experience other, as yet unknown, side effects. Prior to the medical screening, you will receive written information about the study, 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 study. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. 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 29.9 kg/m2. 
• Only non-smokers are allowed to participate in this clinical trial (in the period directly before the study, you have not smoked for at least 6 months).
• 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 use a condom with your female partner and you have been sterilized;
  • 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 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 previous study).
• 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 month. For a microtracer study the timeframe is 30 days. 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. Depending on availability, this can be performed in Groningen or in Utrecht.

The trial consists of one period of stay during which you will stay in the research facility in Groningen (location van Swietenlaan 6 for a total of 22 days (21 nights). Depending on the radioactivity levels in your body at the end of the period of stay you may have to return to the research facility for a maximum of five 24-hour visits, until radioactivity levels are low enough. In addition a follow up phone call will take place.

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.