Study of an investigational compound that is being developed for the treatment of Cystic Fibrosis
- You or your parents are originally from (middle) Africa, Asia, Mediterranean, Middle East or the Caribbean.
- We are specifically looking for males with G6PD deficiency (Glucose-6-phosphate dehydrogenase deficiency) also known as broad bean disease or Favism. If you do not know whether you have a G6PD deficiency or not, but you or your parents are originally from (middle) Africa, Asia, Mediterranean, Middle East or the Caribbean, there is a possibility that you are eligible. We will then do a G6PD deficiency test.
- Your body weight must be more than 50 kg and your Body Mass Index (BMI) is between 18 and 35 kg/m2. The BMI shows the relation between body weight in kilograms and body height in meters.
- Non-smokers as well as light smokers are allowed to participate in this study. Smoking is not allowed from 7 days before dosing and during the clinical stay.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
- The medical screening consists of 2 visits. During the first visit a blood smple will be taken. The blood sample will be used to check if you have a G6PD deficiency. When you have a G6PD deficiency, the actual medical screening will take place during the second visit.
- When youre G6PD-status is already known by PRA, only the regular screening will be done.
You will receive a gross compensation of € 25,- for the blood drawn to check your G6PD-status.
You will receive a gross compensation of € 2.247,- for fully participation in one of the above mentioned groups.
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 period during which you will stay in our research facility in Groningen (location Martini) for 19 days (18 nights).
In consultation, you can determine the start date of your participation. Are you available for 19 days continuous and interested in participation? Please contact us (+31 50-850 7598) and together we will look for a suitable schedule.
G6PD deficiency is a hereditary condition caused by a defect in the G6PD gene.
It plays an important role in protecting red blood cells. In people with insufficient G6PD (deficiency), the red blood cell loses its structure and function, which makes the cells more sensitive to damage. People with G6PD deficiency may experience hemolysis (bursting of some of their red blood cells) during infections, or after ingesting certain foods (for example broad beans) and medications.
Group 2c: dates are flexible (in consultation)Full
19 days stay
- 15 Apr 2018 up to and including 3 May 2018