• The study compound is being developed for the treatment of brain disorders, like Alzheimer's disease and Parkinson’s disease. Alzheimer's disease is a brain disorder that slowly causes memory loss, confusion, and changes in behavior. Parkinson's disease is a nervous system disorder that causes shaking, stiffness, and difficulty with movement.
• In this clinical trial, we will investigate how the study medicine is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants. In part A and B, the effects of the study compound are compared to the effects of a placebo (drug with no active ingredient).
• The study compound or placebo will be administered as a capsule (by mouth) or a cloudy drink. The method of dosing depends on which part you participate in.
• The trial consists several parts. Part A will be divided in two groups: group A1 and group A2. In group A1 and A2 you will receive the study compound or placebo a total of four times during four different study periods. In part B you will receive the study compound or placebo twice a day for 10 days. 
• Only for group A1: cerebrospinal fluid (CSF) will be collected from you during your stay. For group 1A, a CSF sample will be collected once after the administration of the study compound via a lumbar puncture. This is done by 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 levels of study compound and its possible effects in the brain. 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.
• During the study, your heart will be constantly monitored once (part A) or twice (part B) around the administrations for 14 hours. You will get sticky patches (electrodes) on your chest that are attached to a device. At various times, you will have to lie still for 10 minutes without moving, talking or sleeping. You also cannot listen to music, watch TV or use a laptop or phone. However, apart from these moments, you may do so.
• Only for group A1 and group A2: the exact dates for each period are based on the first dosing in the study. These will be confirmed after the first dose.
• Only for group A2: Based on the results of period 1 to 3, it could be decided that period 4 will not take place.

All (potential) 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. Nausea and headache are side effects to be expected in humans. We infer this from information from similar drugs which are already approved and the tests conducted in animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on the 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.
• For part A and part B: you are at least 18 and at most 54 years old. 
• Your weight is at least 50 kg. For part A and part B: your Body Mass Index (BMI) is at least 18.5 and at most 32.0 kg/m². 
• Both non-smokers and occasional smokers (maximum of 7 cigarettes per week) are allowed to participate in this clinical trial. You are not allowed to smoke during your stay in our research facility.

• 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 12 weeks prior to the first compound administration in this clinical trial (counting from the last follow-up of the previous trial).
• 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 group A1: The trial consists of at least 1 period and at most 4 periods during which you will stay in the research facility in Groningen for 4 days (3 nights) every period, followed by 1 short visit after each period. The follow-up visit will take place during your last short visit. The location in Groningen is Van Swietenlaan 6.

Part A group A2: The trial consists of at least 1 period and at most 4 periods during which you will stay in the research facility in Groningen for 4 days (3 nights), followed by 1 short visit after each period. The follow-up visit will take place during your last short visit. The location in Groningen is Van Swietenlaan 6.

Part B: The trial consists of 1 period during which you will stay in the research facility in Groningen for 13 days (12 nights). The follow-up visit will take place 7 to 11 days after your departure from the research facility. The location in Groningen is Van Swietenlaan 6.

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.