Die Studie

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • You can only participate in this trial if you do not smoke or use other nicotine-containing products.

Note: 

  • You cannot participate in the trial if you have participated in another clinical study in the 30 days prior to this trial (counting from the follow-up visit to the screening visit).
  • To determine if you are suitable to participate in this study, 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 adequate 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 only have sexual contact with women;
  • 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 are using a condom in combination with a contraception method used by your female partner (for example the contraceptive pill or intra-uterine device);
  • You have been sterilized or your female partner has been sterilized or is postmenopausal (no period for at least 12 months);
  • You only have sexual contact with men;
  • You are not sexually active according to your lifestyle.

 

Zeitraum

The study consists of 3 parts: part A and part B. You can only participate in 1 group of 1 part. 

  • Part A consists of 1 period during which you will stay in the research facility in Groningen for 4 days (3 nights). 
  • For 1 group of part A the trial consists of 4 periods of 4 days (3 nights) each. For some participants of this group the study will stop after the first period. If this is the case, you will be informed during the study.
  • Part B consists of 1 period during which you will stay in the research facility in Groningen for 17 days (16 nights).

The follow-up visit will take place for each part between 5 to 10 days after your (final) departure from the research facility.

Note: You must be available for all dates to be able to participate in this trial. These are the currently planned dates; however, these may be subject to change.

 

Group A6  
stay  
  • 1 Sep 2022 up to and including 4 Sep 2022
 
follow-up  
  • by appointment between 9 Sep 2022 up to and including 14 Sep 2022
 

 

Group B1a  
stay  
  • 27 Sep 2022 up to and including 13 Oct 2022
 
follow-up  
  • by appointment between 18 Oct 2022 up to and including 23 Oct 2022
 

 

Group B1b  
stay  
  • 28 Sep 2022 up to and including 14 Oct 2022
 
follow-up  
  • by appointment between 19 Oct 2022 up to and including 24 Oct 2022
 

For some participants in this group, the study ends after the second period. If this is the case, you will be informed during the clinical trial.

Aufwandsentschädigung

  • For participating in part A with 4 periods you will receive a gross compensation of € 3445.
  • For participation in part B you will receive a gross compensation of € 3055.

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.