• The study compound is a new compound that may potentially be used for the treatment of epilepsy, amyotrophic lateral sclerosis (ALS), and pain. Epilepsy is a brain disorder. Normally the cells in your brain transmit electrical signals to each other. These signals allow you to perceive things and move properly. During an epileptic seizure, the brain cells suddenly send out many signals at once, very rapidly. This causes a kind of short circuit, which prevents your brain from functioning normally. What happens during a seizure depends on the part of the brain where the “short circuit” begins. ALS is a rare disease where nerve cells in the brain and spinal cord that are responsible for movement become damaged and die. This results in loss of coordination (being able to make movements work well together), muscle mass, muscle strength, ability to speak, swallowing function, and eventually respiratory function.
• The study compound has been administered to healthy participants before.
• The study consists of four groups. In all groups you will receive the study compound twice a day for 14 days, and on day 15 the study compound will be given one more time.  You are allowed to participate once in the study, in one of the groups.
• The study compound will be given as granules mixed in water (group 1-3) or in a soft food, like yoghurt (group 4) and you will take this by mouth.

The compound has already been tested in healthy participants. In these clinical trials, the following side-effects were observed most often: headache, nausea/vomiting, dizziness, feeling lightheaded, fatigue, sleepiness and diarrhea. 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 any questions you may have. Once everything is clear to you, you can decide whether 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.

• You are a healthy male or female.
• You are at least 18 and at most 65 years old.
• Your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m². 
• Both non-smokers and light or occasional smokers (at most 5 cigarettes per day) are allowed to participate in this clinical trial. You are not allowed to smoke from 24 hours prior to the screening visit, from 48 hours prior to admission in the research facility and during your further stay there

• 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 an 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 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 in combination with an additional method of contraception used by your fertile female partner;
• You have been sterilized or your female partner has been sterilized or has passed the menopause (no periods for at least 12 months);
• 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 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous study).
• 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 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 18 days (17 nights), followed by 2 short visits.

The follow-up visit will take place during the last short visit.

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