• The study compound is a new compound that may potentially be used for the treatment of amyotrophic lateral sclerosis (ALS). 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, muscle mass, muscle strength, ability to speak, swallowing function, and eventually respiratory function. ALS gets worse over time and current treatments only bring about a small increase in lifespan. There is no cure.
• The study compound is being developed as a potential treatment for ALS because lab tests have shown that it can reduce the overstimulation of cells. There appears to be a connection between increased activity in nerve cells in the brain and spine and a shorter lifespan in people with ALS.  
• The study consists of 4 periods of stay. You will be given the study compound 4 times, once in each of the 4 different periods. In the first period, you will receive the study drug after fasting (without having eaten). In the other 3 periods, you will receive the study drug after a high-fat breakfast.

The compound has already been tested in healthy individuals. In these studies, the following side-effects were observed most often: headache, nausea/vomiting, dizziness and light-headedness. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the study, which also describes the possible side effects. This information will also be discussed with you during 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 study. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. 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 70 years old.
• Your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 5 cigarettes per day). During your stay in our research facility, 24 hours prior to the medical screening, 2 days prior to your stay, and prior to the last visit you are not allowed to smoke.

• As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions, from at least 28 days prior to the first compound administration in this trial:
  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You are using 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 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 with 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.

Let op:

• You cannot participate in the trial if you have participated in another clinical trial in the month prior to the first compound administration in this clinical trial (counting from the follow-up visit).
• You cannot participate if you have participated in a previous trial investigating the same study compound, during the telephone screening we will check if this is applicable for you.

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 4 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 4 days (3 nights). The follow-up visit will take place 5 – 7 days after your departure from the research facility after the fourth period. The study will take approximately 4 months from the screening until the follow up-visit.

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.