• The study compound is a new compound that could potentially be used to treat a certain type of high blood pressure. The heart pumps blood into the arteries. This creates a certain pressure in the blood vessels: blood pressure. This pressure is necessary to pump blood around the body, ensuring that all organs and muscles receive sufficient oxygen. However, if blood pressure is very high or high for a long period of time, symptoms can arise. The type of high blood pressure for which the compound was developed in this trial is called pulmonary arterial hypertension. In this condition, the blood pressure in the arteries that run from the heart to the lungs is too high. These arteries have become narrow or stiff, making it harder for blood to flow through them. As a result, the heart must work harder. This can lead to symptoms such as shortness of breath, fatigue, chest pain, dizziness, or swelling in the legs and ankles. Over time, this extra strain can weaken the heart.In this trial, we will investigate how quickly and to what extent the new compound is absorbed, transported, and eliminated from the body. We will also investigate how safe the study compound is and how well it is tolerated when it is used by healthy male participants.
• The study compound will be administered once as a capsule by mouth with 240 milliliters of water.
• 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, 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 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. Read more about these kind of trials.

The study compound has been administered to humans before in previous drug studies. In the previous studies, the study compound was well tolerated. There were no significant side effects. You may however experience 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 55 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 29.9 kg/m². 
• You do not smoke and you have not used any nicotine-containing products in the last 3 months prior to the screening for this trial.
• You can only participate if you meet one of the following conditions:
  • You use a condom during sex up until 3 months after the last administration in this trial;
  • 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 30 days prior to the screening for this clinical trial (counting from the last compound administration). This may be 6 months for certain trials. 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. Exceptions to this are trials with an extremely low dose of radioactivity  (so called 14-C microdose trials). Please contact us for more information.
• 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 (location van Swietenlaan 6) for 11 days (10 nights). Depending on the amount of radioactivity that remains in your body, 1 to 4 24-hour visits will follow (1 overnight stay per 24-hour visit).

The follow-up visit will take place 5 to 10 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.