The study compound is a new compound that may potentially be used for the treatment of pulmonary fibrosis. Pulmonary fibrosis is an incurable disease where there is scarring (fibrosis) of the lungs. This makes it harder for the lungs to absorb oxygen from the air. Less oxygen in the blood leads to shortness of breath. And the more scarring, the smaller the contents of the lungs become and the greater the shortness of breath.

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 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 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.

The study consists of two groups, you can only participate in one of the groups. If you participate in group A you will receive the study compound once as an oral solution. If you participate in group B you will receive the study compound once as 3 tablets via the mouth and in addition you will receive the study compound as an infusion in a blood vessel, for a duration of approximately 15 minutes.

The study compound has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals.

• You are a healthy male.
• You are at least 18 and at most 55 years old.
• Your Body Mass Index (BMI) is at least 18.5 and at most 30.0 kg/m2. 
• Both non-smokers and light smokers (maximum of 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 are using a condom in combination with an additional contraception method used by your fertile female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months) and you use a condom;
  • 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 60 days 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. These trials have a negligible amount of radiation burden, 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.

Group A
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). If the amount of radioactivity that you have excreted is not low enough after 8 days, you have to come back to the research facility weekly for a maximum of 2 times for a 24-hour visit (1 night stay per 24-hour visit), until the radioactivity is low enough. The follow-up will at least take place at least 3 days after the last departure from our research facility.

Group B
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). The follow-up will take place 1 to 11 days after departure from our research facility.

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.