The trial

Clinical trial of a new compound that is being developed for the treatment of Alzheimer’s disease.

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your Body Mass Index (BMI) is at least 18 and at most 30 kg/m2 (inclusive). 
  • 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 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.

As a female you can only participate if you are not pregnant, not breastfeeding and meet one of the following conditions:

  • You are using an 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 with your female partner;
  • 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.

Period

The trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6). The first period consists of 6 days (5 nights), followed by one short visit. The second period consists of 14 days (13 nights), followed by two short visits. The follow-up visit will take place 2 to 6 days after your last short 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.

 

Group 1  
period of stay  
  • 6 up to and including 11 Juni 
  • 16 up to and including 29 Juni
 
visits  
  • 13 Juni
  • 1 Juli
  • 3 Juli
 
follow-up The follow-up will be on July 5, 8 or 9.

Compensation

  • You will receive a gross compensation of € 5371 for participation in one of the groups of the study.
  • Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

Additional information

  • The study compound is being developed for the treatment of Alzheimer’s disease.
  • In this clinical trial, we investigate whether an approved compound that is already available on the market (itraconazole) has an influence on the way the  study compound is processed and eliminated by the body. Furthermore, we investigate how well the administration of both compounds is tolerated when they are used by healthy participants.
  • The study consists of 2 periods. In the first period you will receive a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the second period you will receive a single dose of the study compound, and you will also receive Itraconazole. This will also be administered in the form of a capsule to swallow. You will receive Itraconazole once daily for 12 days. Itraconazole is used to treat fungal infections.
  • You can only participate in one group of this trial.
Wallet

Want to participate in this trial?

You can! Fill in your information in this application form. The clinical trial centre responsible will then contact you about your participation.

I want to participate

Attention: Smoking volunteers may smoke 5 cigarettes per day at most.