In this clinical trial, we will investigate how quickly and to what extent the study compound is absorbed, transported, broken down, and eliminated from the body. We will also investigate how safe the study compound is and how well it is tolerated when it is given to healthy people. The compound has already been studied in patients with cancer. With the current trial, we aim to better understand how a healthy body responds to the study compound, without the additional effects of cancer or cancer treatments.

This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling the compound allows researchers to study how quickly and to what extent it 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 2.5 months. 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.

You will receive the study compound once daily for 8 days in the form of 3 tablets per day, taken by mouth with water. On day 9, you will receive the radioactive labeled study compound in the form of 6 capsules, taken by mouth with water.

• You are a healthy female.
• You are at least 18 and at most 55 years old.
• Your Body Mass Index (BMI) is at least 18.0 and at most 35.0 kg/m². 
• You have not smoked or did not use any nicotine-containing products within the 3 months prior to admission day.
• You can only participate if you meet one of the following conditions:
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized.

Note: 

• 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.
• You cannot participate in the trial if you have participated in another clinical trial 4 weeks prior to the day of admission of this clinical trial (counting from the last dosing in the previous trial).
• You cannot participate in this trial if you have participated in more than two other studies with radiolabeled study compounds in the past 12 months. There are some additional radiation exposure requirements; please contact us for more information.

The trial consists of 1 period during which you will stay in the research facility in Groningen for a minimum of 19 days (18 nights) and a maximum of 24 days (23 nights). How long you stay depends on the amount of radioactivity that you still have in your body.
The follow-up phone call will take place 15 days after the end of the maximum stay period in the research facility.

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