Liver disease
- Geschlecht Beides
- Alter von 18 bis 65
- Rauchgewohnheiten Nicht
- BMI von 18 bis 30
- Berechnen Sie Ihren BMI hier
Study of a new compound that is being developed for the treatment of non-alcoholic fatty liver disease
Besonderheiten (auf Englisch)
- You are a healthy male or female.
- You are between 18 and 65 years old.
- Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
- You have not participated in any other drug study within 30 days preceding the first administration of this study compound (counting from the last administration). For specific studies this could be 6 months. You can call us to get more information about this.
- As a male, you are only allowed to participate in this study if;
- You use a condom;
- or you have been vasectomized before the start of the study;
- or your female partner is postmenopausal (at least 12 months without menstruation) or surgically sterilized;
- or you are only sexually active with a male;
- or you are fully abstinent (not sexually active) in accordance with your lifestyle.
- As a female you are only allowed to participate in this study if:
- Your male partner uses a condom and you use a non-hormonal intrauterine device, diaphragm, cervical cap, or you have a bilateral tubal ligation or fallopian tube inserts (Essure procedure);
- you have been postmenopausal (at least 24 months without menstruation);
- or you had a complete hysterectomy 3 months prior to dosing or a bilateral oophorectomy before the start of the study;
- or you are only sexually active with a female;
- or you are fully abstinent (not sexually active) in accordance with your lifestyle.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
Vergütung (auf Englisch)
You will receive a gross compensation of € 1270 for full participation in part A (group 1,2,4,5 and 6).
If you participate in group 3 of part A, consisting of two periods, you will receive € 2625 for full participation.
You will receive a gross compensation of € 2821 for full participation in part B (group 7 to 9).
Travel 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 round trip, irrespective of the method of transportation.
Periode und Studie (auf Englisch)
The study consists of two different parts, part A and part B.
Part A consists of 5 groups (group 1,2,4,5 and 6) with a period of 8 days (7 nights) in our research facility in Groningen. Group 3 of part A will consist of 2 periods of 8 days (7 nights), where you go home in between those periods for one day. For all the groups you will have to come back, 2 days after you leave our research facility, for a follow-up visit.
Part B consists of 3 groups (group 7 to 9) with each 20 days (19 nights) in our research facility in Groningen. 3 days after you leave our research facility you will have to come back once for a follow-up visit.
To take part in the study, you need to be available for all dates of your chosen group. You can find the exact dates for each group on our website. If the dates change you will be notified as soon as possible.
Group 2a |
8 days stay25 Oct 2020 up to and including 1 Nov 2020 |
follow-up3 Nov 2020 |
Group 3 |
7 days en 8 days stay9 Nov 2020 up to and including 16 Nov 2020 8 Dec 2020 up to and including 14 Dec 2020 |
follow-up16 Dec 2020 |
Group 4 |
8 days stay22 Nov 2020 up to and including 29 Nov 2020 |
follow-up1 Dec 2020 |
Group 5 |
8 days stay14 Dec 2020 up to and including 21 Dec 2020 |
follow-up24 Dec 2020 |