Die Studie

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2. 
  • You have not smoked regularly for at least 3 months prior to screening. Occasional smoking (no more than 1 cigarette per day) may be allowed, except you cannot smoke 21 days prior to admission in the research facility.

?Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the  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. 

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions from 4 weeks prior to the first administration in this trial:

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
  • You are using a copper 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 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.

Zeitraum

The trial consists of two parts: part A and part B. You can only participate (in one group of) one part in this trial.

Part A: This part consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 5 to 7 days after your departure from the research facility.

Part A food effect: This group consists of 2 periods during which each period you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 5 to 7 days after your last departure from the research facility.

Part B: This part consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 15 days (14 nights). The follow-up visit will take place 5 to 7 days after your departure from the research facility.

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

 

Group B1  
period of stay  
  • 5 up to and including 19 Mai
 
follow-up  
  • 24 Mai
 

 

Group B2  
period of stay  
  • 2 up to and including 16 Juni
 
follow-up  
  • 21 Juni
 

Aufwandsentschädigung

  • You will receive a gross compensation of € 1646 for participation in one of the groups of part A.
  • You will receive a gross compensation of € 2948 for participation in the food effect group in part A
  • You will receive a gross compensation of € 3599 for participation in one of the groups of part B.

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.