• The trial consists of 3 parts: part 1a, 1b, and 1c. You can only participate in 1 part.
• The study compound could potentially be used to treat cardiovascular disease caused by arteriosclerosis. Arteriosclerosis is caused by the accumulation of various substances in the arterial walls. This causes the walls to gradually thicken and become less elastic. This may lead to narrowing of the blood vessel, resulting in organs or muscles receiving insufficient blood and oxygen. Ultimately, serious problems such as heart attacks or strokes can occur. In part 1a and 1b, the study compound will be given as a liquid. In part 1c, the study compound will be given as capsules by mouth. In part 1a you will receive the study compound once, in part 1b you will receive the study compound once or twice a day for 10 days, and in part 1c you will receive the study compound twice (once per period).
• Part 1a and 1b: From 24 hours before the administration of the study compound until 24 hours after, your heart will be monitored continuously. For this, you will have electrodes placed on your chest that are attached to a device. While you are connected to the device, you cannot take a shower and you have to be as relaxed as possible and prevent sweating. From the time you are connected, you can no longer use electric devices (razor, electric toothbrush, hairdryer). You may also not wear jewelry or a watch. At certain times you will be asked to remain lying down for 15 minutes without moving, talking or sleeping. During these 15-minute periods you may also not listen to music, watch television or use a laptop, media player or phone.
• Part 1c: in 1 period you will take the study compound after having eaten a high-fat breakfast.

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 animal studies, the study compound affected the heart rate and blood pressure. It also appeared that the heart needed longer to recharge between beats. This change may increase the risk of dangerous, irregular heart rhythms. In this trial, the dose of the study compound is much lower than that given to animals and your heart rate, blood pressure, and heart rhythm will be measured regularly.  In rare cases (<0.1%), serious side effects can occur during the first administration 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 the screening physician or nurse any question you may have. 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.
• You are at least 18 and at most 50 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m². 
• Part 1a and 1c: both non-smokers and light smokers or occasional smokers (at most 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.
• Part 1b: you do not smoke and you have not used any nicotine-containing products for at least 1 month prior to the medical screening.
   
• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You use hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You use a copper intra-uterine device;
  • 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 only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male you can only participate if you meet one of the following conditions:
  • You use a condom during sex with a female partner;
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Note:

You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to the first compound administration in this clinical trial (counting from the follow-up visit).
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 1a: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 1 short visit. The follow-up visit will take place 2 - 6 days after the short visit.

Part 1b: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 14 days (13 nights), followed by 1 short visit. The follow-up visit will take place 3 - 7 days after the short visit.

Part 1c: The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). Both periods will be followed by 1 short visit. The follow-up visit will take place 3 - 7 days after the final short visit.

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