The trial

  • You are a healthy male or female.
  • You are at least 18 and no more than 55 years old.
  • You weigh at least 50 kg and your Body Mass Index (BMI) is higher than or equal to 18.5 and lower than or equal to 32.0 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
  • You did not smoke, vape, or use nicotine patches or sprays, and nicotine chewing gum in the 3 months prior to screening.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first study drug administration in this clinical trial (counting from the follow-up visit of the previous trial). This might be longer for certain trials, please contact us for more information.
  • To determine if you are suitable to participate in this trial, you will undergo a 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 contraception (for example the contraceptive pill or 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 contraception method used by your female partner;
  • You have been sterilized and 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 only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Period

The trial consists of 3 periods during which you will stay in the research facility in Groningen for 5 days (4 nights) per period. The follow-up visit will take place between 2 to 4 days after your last departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The location in Groningen is Van Swietenlaan 6.

 

Group 2  
period of stay  
  • 23 up to and including 27 April 
  • 1 up to and including 5 Mai 
  • 9 up to and including 13 Mai
 
follow-up on appointment between May 15, 2024 and May 17, 2024

Compensation

You will receive a gross compensation of € 3599 for full participation in one of the cohorts.

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.