• The study compound is a new compound that may potentially be used for the treatment of Alzheimer's disease.  Alzheimer's disease is described as an increasing deterioration of the various activities performed by the brain. This makes thinking, acting and interacting with others increasingly difficult. The disease usually begins with memory loss and difficulty with language. In the final stage, a person with Alzheimer's can no longer perform everyday things. The patient then also becomes sad, angry or aggressive toward others. In this study, we will compare capsules in different forms. The study compound has been given to humans before as capsules (called Phase 1 capsules) in previous studies. Two versions of a new capsule containing the study compound will be tested in this study. These two variants are called Phase 2 capsules. The uptake, breakdown, and elimination of these capsules will be compared in this study. In addition, we will investigate whether eating food just before taking the Phase 2 capsules influences how the body handles the study compound. Furthermore, we will investigate how safe the study compound capsules are and how well they are tolerated when they are used by healthy subjects.

• You will receive the study compound 3 times, each time in the form of capsules that you must swallow:
  • The Phase 1 capsule after a night of not eating and drinking,
  • The Phase 2 capsule after a night of not eating and drinking,
  • The Phase 2 capsule after a high-fat breakfast.

The compound has already been tested in healthy individuals, and overall it was safe and well-tolerated. The first study done in humans with the study compound involved 127 healthy participants of which 99 were treated with the study compound. The study looked at how safe the study compound was and if there were negative effects on the wellbeing of the participants. The dose you will receive in this study (120 mg) will be lower than the highest doses that have already been tested in previous studies. Overall, it was found that the study compound was safe and well-tolerated. All reported side effects were mild or moderate in severity. The most common side effects were nausea, indigestion, headache, diarrhea and vomiting.

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 questions to the screening physician or nurse. Once everything is clear to you, you can decide 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 smokers or occasional smokers (maximum of 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.

Note

• You cannot participate in the trial if you have participated in another clinical trial in the 60 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.

• 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 an intra-uterine device (with or without hormones) 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 with your fertile female partner, unless you are sterilized;
  • You are using a condom with your pregnant partner, even if you are sterilized;
  • 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.

The trial consists of 3 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights).

The last period will be followed by 1 short 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.