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Inflammatory bowel disease

Geschlecht Beides

Alter von 18 bis 50

Rauchgewohnheiten Nicht

BMI von 18 bis 30

Berechnen Sie Ihren BMI hier

Ort der Studie

 

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

 

Besonderheiten (auf Englisch)

  • 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.

Vergütung (auf Englisch)

You will receive a gross compensation of € 1,181,- for full participation in group 4a, 4b, 5a, 5b, 6a, 6b, 7a or 7b.
You will receive a gross compensation of € 3,401,- for full participation in group 3a or 3b.

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.

 

Periode und Studie (auf Englisch)

The study consists of 2 parts:
Groups 4 and 5 of 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.

Groups of 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.

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 5b

 

6 days stay

1 Dec 2020 up to and including 6 Dec 2020

 

follow-up

9 Dec 2020

 

There will also be a follow-up by phone

Group 7

2× 2 days, 3 days en 7 days stay

15 Dec 2020 up to and including 17 Dec 2020

23 Dec 2020 up to and including 24 Dec 2020

30 Dec 2020 up to and including 31 Dec 2020

6 Jan 2021 up to and including 12 Jan 2021

short visit

14 Jan 2021

21 Jan 2021

4 Feb 2021

18 Feb 2021

note

Follow-up by appointment between 2 - 6 March 2021.

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