Study of a new compound that is being developed for the treatment of acute swelling of skin around the eyes and mucous membranes in the pharynx (hereditary angioedema): a rare genetic disorder
- You are a non-smoker
- 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.
- The new compound will be labelled with 14 Carbon (14C) and is thus radioactive. In this way the compound can be traced in your blood, urine and feces.
- To determine if you are eligible for participation in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.907,- for participation in the above mentioned group. For every necessary 24-hour visit, you will receive a gross compensation of € 120,- per visit.
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 1 study period during which you will stay in our research facility in Groningen (location Martini). You will stay a maximum of 22 days (21 nights) and a minimum of 16 days (15 nights) depending on the speed of radioactive release by the body through urine and feces. The amount of radioactivity in urine and feces will be measured regularly, if the radioactivity levels in urine and feces are below the pre-defined levels, you will be allowed to leave the research center.
If the amount of radioactivity in your urine and/or feces are not below the pre-defined levels after 21 days, you will return to the research center for one to four 24-hour collection of urine and feces.
Please note: You have to be available for all dates for the group to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
16 days stay
- 26 Sep 2017 up to and including 11 Oct 2017
- 17 Oct 2017
- 24 Oct 2017 up to and including 25 Oct 2017
- 31 Oct 2017 up to and including 1 Nov 2017
- 7 Nov 2017 up to and including 8 Nov 2017
- 14 Nov 2017 up to and including 15 Nov 2017