The trial

  • You are a healthy male or female.
  • You are between 22 and 65 years old.
  • Your weight is at least 50.0 kg and at most 110.0 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 5 cigarettes daily). 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 30 days prior to the first compound administration in this clinical trial (counting from the follow-up).
  • 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 continuous hormonal contraception (the pill or a hormonal IUD);
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized (ovariectomy).

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom in combination with an additional contraception method used by 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.

Period

  • Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights), followed by 8 short visits. The follow-up will be during the final short visit.

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

 

Group A1b  
9 Tage Aufenthalt  
  • 13 Jul 2023 bis einschl. 21 Jul 2023
 
kurzer Besuch  
  • 25 Jul 2023
  • 28 Jul 2023
  • 4 Aug 2023
  • 11 Aug 2023
  • 18 Aug 2023
  • 25 Aug 2023
  • 1 Sep 2023
 
Nachuntersuchung  
  • 8 Sep 2023
 

 

Group A2a  
9 Tage Aufenthalt  
  • 3 Aug 2023 bis einschl. 11 Aug 2023
 
kurzer Besuch  
  • 15 Aug 2023
  • 18 Aug 2023
  • 25 Aug 2023
  • 1 Sep 2023
  • 8 Sep 2023
  • 15 Sep 2023
  • 22 Sep 2023
 
Nachuntersuchung  
  • 29 Sep 2023
 

 

Group A2b  
9 Tage Aufenthalt  
  • 6 Aug 2023 bis einschl. 14 Aug 2023
 
kurzer Besuch  
  • 18 Aug 2023
  • 21 Aug 2023
  • 28 Aug 2023
  • 4 Sep 2023
  • 11 Sep 2023
  • 18 Sep 2023
  • 25 Sep 2023
 
Nachuntersuchung  
  • 2 Okt 2023
 

 

Compensation

You will receive a gross compensation of € 3916 for participation in one of the groups of part A. F

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.