Die Studie

The tolerability and safety after a single dose of the study compound will be investigated in this trial. From 24 hours prior to administration until 48 hours after administration on day 1 of the clinical trial your heart rhythm will be monitored. This is done by means of stickers (electrodes) on the upper body that are attached to a device (recorder).

  • You are a healthy male or female
  • You are between 18 and 55 years old.
  • Your body weight is at least 45 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m2.
  • Both non-smokers and occasional smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to 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 sufficient contraception (for example the contraceptive pill or an intra-uterine device) in combination with a condom;
  • You have passed the menopause (no period for at least 12 months)
  • You have been sterilized or your male partner has been sterilized;
  • You are not heterosexually active according to your lifestyle.

As a male you can only participate if you have been sterilized for at least 3 months prior to the medical screening.

Zeitraum

The trial consists of 1 period during which you will stay in the research facility in Groningen for 9 days (8 nights), followed by 2 short visits. The follow-up visit will take place between 14 and 21 days after your departure from the research facility.

PLEASE NOTE: You must be available for all dates to be able to participate in this trial. The current dates of the trial will be published on our website. These are the currently planned dates; however, these may be subject to change.

 

Group A4b  
9 days stay  
  • 8 May 2022 up to and including 16 May 2022
 
short visit  
  • 19 May 2022
  • 22 May 2022
 
follow-up  
  • by appointment between 30 May 2022 up to and including 6 Jun 2022
 

 

Group A4c  
9 days stay  
  • 13 Jun 2022 up to and including 21 Jun 2022
 
short visit  
  • 24 Jun 2022
  • 27 Jun 2022
 
follow-up  
  • by appointment between 5 Jul 2022 up to and including 12 Jul 2022
 

 

Group A4d  
9 days stay  
  • 21 Jun 2022 up to and including 29 Jun 2022
 
short visit  
  • 2 Jul 2022
  • 5 Jul 2022
 
follow-up  
  • by appointment between 13 Jul 2022 up to and including 20 Jul 2022
 

 

Group B1a  
9 days stay  
  • 19 Jul 2022 up to and including 28 Jul 2022
 
short visit  
  • 31 Jul 2022
  • 3 Aug 2022
  • 6 Aug 2022
 
follow-up  
  • by appointment between 11 Aug 2022 up to and including 14 Aug 2022
 

 

Group B1b  
9 days stay  
  • 27 Jul 2022 up to and including 5 Aug 2022
 
short visit  
  • 8 Aug 2022
  • 11 Aug 2022
  • 14 Aug 2022
 
follow-up  
  • by appointment between 19 Aug 2022 up to and including 22 Aug 2022
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 2030 for participation in one of the groups of part 1.
  • You will receive a gross compensation of € 2126 for participation in one of the groups of part 2.
  • You will receive a gross compensation of € 1982 for participation in one of the groups of part 3.

Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.