PRA-19422X

Inflammatory bowel disease

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

Particulars

  • You are healthy and between 18 and 55 years old.
  • You do not smoke.
  • Your Body Mass Index (BMI) is between 18 and 32 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.
Calculate BMI

Compensation

You will receive a gross compensation of € 1,031,- for full participation in group 2b, 3a, 3b, 5a, 5b, 6a, 6b, 7a, 7b, 8a or 8b.
You will receive a gross compensation of € 3,051,- for full participation in group 4a or 4b.
For full participation in group 9, 10, 11, 12, 13  you will receive a gross compensation of € 3,179,-.

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.

Period of stay and research

The study consists of 2 parts:
Group 1 or 2 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.

Sign up for one of the following study groups

Group 2b

6 days stay

  • 4 Feb 2020 up to and including 9 Feb 2020

follow-up

  • 12 Feb 2020

there will also be a follow-up by phone

€ 1.031,- Select

Group 3b

6 days stay

  • 25 Feb 2020 up to and including 1 Mar 2020

follow-up

  • 4 Mar 2020

note

er volgt tevens een telefonische nakeuring

€ 1.031,- Select

Group 4a

3× 6 days stay

  • 23 Mar 2020 up to and including 28 Mar 2020
  • 6 Apr 2020 up to and including 11 Apr 2020
  • 4 May 2020 up to and including 9 May 2020

follow-up

  • 12 May 2020

there will also be a follow-up by phone

€ 3.051,- Select

Group 4b

3× 6 days stay

  • 24 Mar 2020 up to and including 29 Mar 2020
  • 6 Apr 2020 up to and including 11 Apr 2020
  • 4 May 2020 up to and including 9 May 2020

follow-up

  • 12 May 2020

there will also be a follow-up by phone

€ 3.051,- Select
Show full groups

Group 1a

Full

6 days stay

  • 13 Jan 2020 up to and including 18 Jan 2020

follow-up

  • 21 Jan 2020

there will also be a follow-up by phone

€ 1.031,- Select

Group 1b

Full

6 days stay

  • 14 Jan 2020 up to and including 19 Jan 2020

follow-up

  • 22 Jan 2020

there will also be a follow-up by phone

€ 1.031,- Select

Group 2a

Full

6 days stay

  • 3 Feb 2020 up to and including 8 Feb 2020

follow-up

  • 11 Feb 2020

there will also be a follow-up by phone

€ 1.031,- Select

Group 3a

Full

6 days stay

  • 24 Feb 2020 up to and including 29 Feb 2020

follow-up

  • 3 Mar 2020

there will also be a follow-up by phone

€ 1.031,- Select