Die Studie

Study of a new compound that is being developed for the treatment of inflammatory bowel disease.

  • You are healthy and between 18 and 55 years old.
  • You do not smoke.
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Women are only allowed to participate in this study if you meet one of the following criteria:
    • You are using a copper intrauterine device.
    • Or you have been postmenopausal for at least one year.
    • Or you (or your partner) have been surgically sterilized.
    • Or you are not sexually active which is in line with your lifestyle.
    • Or have a female partner.
  • Men are only allowed to participate in this study if you meet one of the following criteria:
    • You use a condom.
    • Or you (or your partner) have been surgically sterilized.
    • Or you are not sexually active which is in line with your lifestyle.
    • Or have a male partner.
  • You cannot participate in this study if you have received treatment with another study drug within 90 days prior to dosing of the current study drug.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. Based on availability, this can take place in Groningen or Utrecht.

Zeitraum

The study consists of 2 parts:

Part 1 consist of 1 period during which you will stay in our research facility in Groningen for 6 days (5 nights). Group 3 of part 1 consists of 3 periods during which you will stay in our research facility in Groningen for 6 days (5 nights) each. For every group of part 1 there will be a follow-up visit 3 days after your (last) discharge from the research facility. Finally, there will be a telephone follow-up 7 days later.

Part 2 consist of 1 period during which you will stay in our research facility in Groningen for 19 days (18 nights), followed by 1 short visit 4 days after discharge. Finally there will be a follow-up visit 3 weeks after this short visit.

For group 15a and 15b of part 2 the study consists of 1 period during which you will stay in our research facility in Groningen for 15 days (14 nights), followed by 1 short visit 4 days after discharge. Finally there will be a follow-up visit 3 weeks after this short visit.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Group stay short visit follow-up
15a 15 Aug 2021 up to and including 29 Aug 2021 2 sep 2021 23 Sep 2021
15b 22 Aug 2021 up to and including 5 Sep 2021 9 sep 2021 30 Sep 2021

 

Aufwandsentschädigung

You will receive a gross compensation of €1181 for full participation in Part 1 or €3401 for full participation in group 3 of Part 1. For full participation in Part 2 you will receive a gross compensation of €3329. For full participation in group 15a and 15b of Part 2 you will receive a gross compensation of €2832. Travelling 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 return, regardless of the mode of transportation.