• The study compound is being developed for the treatment of Alzheimer's disease. Alzheimer's disease is a brain disorder that slowly causes memory loss, confusion, and changes in behavior.
• In this clinical trial, we are investigating how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
• The study compound or placebo will be administered as a tablet (by mouth). A placebo is a compound without an active ingredient.
• The trial consists of several parts. In part A you will receive the study compound or placebo once. For one group in part A (group A3) the trial will consist of two periods where you receive the new compound or placebo once each period. The effect of food on this new compound will be investigated in this group. In part B you will receive the study compound or placebo once daily for 10 days. 
• In all parts: cerebrospinal fluid will be collected from you at 2 different times during the stay through a lumbar puncture. This involves inserting a thin needle between two vertebrae in the lower back. This procedure is not entirely without risk. Collecting this fluid is important because it provides an indication of the amount of the study compound in the brain and its possible effects after each dose of the study compound. The lumbar puncture will be performed by an experienced specialist. The specialist will use numbing medication to minimize any pain or discomfort from the needle.

All (possible) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration of new compounds to humans. The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. 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. 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 or female.
• Part A and B: 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 18.5 and at most 32.0 kg/m². 
• You do not smoke and do not use any nicotine-containing products. You also do not have a history of alcohol abuse or drug addiction.

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper intra-uterine device in combination with a condom;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized or your male partner has been sterilized;
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.
• 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;
  • 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 follow-up visit). For some clinical trials this period could be longer, 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.

Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights). The follow-up visit will take place 5 to 9 days after your departure from the research facility.

Part A group A3: The trial consists of 2 periods during which you will stay in the research facility in Groningen for 9 days (8 nights) during each period. The follow-up visit will take place 5 to 9 days after your departure from the research facility.

Part B: The trial consists of 1 period during which you will stay in the research facility in Groningen for 18 days (17 nights). The follow-up visit will take place 6 to 10 days after your departure from the 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. The location in Groningen is Van Swietenlaan 6.