• The study compound is being developed as a new treatment for certain types of cancer. Some tumors that have a certain kind of genetic activity could potentially be treated with the compound.
• 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.
• This study consists of 2 parts. In part 1 you will receive the compound once via the mouth as a drink (suspension). In period 2 you will receive the compound once via the mouth as a drink (suspension), and once via an intravenous infusion (solution of the compound administered directly in the blood vessel). In period 1 the drink is radioactively labeled, in period 2 only the intravenous infusion is radioactively labeled.
• In both periods, 30 minutes before you receive the drink and 8 hours after taking the drink you will receive medication to prevent vomiting.

The compound has already been tested in healthy individuals and patients with cancer. When healthy individuals received the compound once via the mouth, mild side-effects were observed. The following side-effects were observed most often: nausea, vomiting, diarrhea, dizziness, and headache. 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 more than 50 kg and your Body Mass Index (BMI) is at least 17.5 and at most 32.0 kg/m2. 
• You do not smoke and do not use any nicotine-containing products.

• 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 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 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 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.
• 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 both of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for at least 6 days (5 nights). Based on your lab values it is possible that you will have to stay longer after the first period, this can be up to a maximum of 14 days after your arrival at the research facility. Since period 2 starts on the 14^th day after the arrival for period 1, in that case you will remain at the research facility. After period 2 it is also possible that you will have to stay longer, up to a maximum of 3 days. Your stay can therefore be a maximum of 23 days (22 nights). 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.