• The study compound is a new compound that may be used for future treatment of breast cancer. The study compound is able to suppress tumor growth in breast tissue by indirectly inhibiting the female estrogen hormone.
• The study consists of two periods. During the first period you will receive the study compound once as an intravenous infusion, which will take around 30 minutes, during the second period you will receive the study compound once as a tablet after a high-fat breakfast.
• The study compound has already been administered to 217 patients with breast cancer, in addition it has been extensively tested in the laboratory and in animals.
• The compound has already been tested in patients with breast cancer. In these clinical trials, the following side-effects were observed most often: fatigue, nausea, arthralgia, hot flush and constipation. 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 the screening physician or nurse questions. 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.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

• You are a healthy male or a female (post-menopausal or sterile).
• You are at least 18 and at most 65 years old.
• Your weight is at least 45 kg and your Body Mass Index (BMI) is at least 16.0 and at most 32.0 kg/m2. 
• Both non-smokers and light smokers or occasional 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.
• As a female you can only participate if you are of non-childbearing potential. This means you meet one of the following conditions:
  • You have been sterilized;
  • You have passed menopause (no periods for at least 12 months).
• As a male 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 (for instance the pill or an intrauterine device);
  • You have been sterilized or your female partner is sterilized or has passed 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.

Please 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 dosing). For some study compounds this can be longer. This will be discussed during your telephone screening.

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 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights) for each period. The follow-up visit will occur 21 days after the final departure from the research facility as a follow-up phone call.

Note: You must be available for all dates to be able to participate in this clinical trial.