Study of a new compound that is being developed for the treatment of acromegaly
- You do not smoke
- Your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
- In case you have a female partner of childbearing potential, you and your partner should both use contraceptive measures during the study.
- Group 1 of the study is with a radioactive (14C) labeled compound that will be given as a combination of a capsule and infusion. This has a negligible amount of radiation (microdose): less than the natural background radiation that is released from water, food, air and construction materials in one month.
- Group 2 of the study is with a radioactive (14C) labeled compound that will be given orally as a drink.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 697,- for participation in group 1.
For participation in group 2, you will receive a gross compensation of € 1.607,-. For every necessary 24-hour visit of group 2, 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 2 groups.
Group 1: This group consists of 1 period during which you will stay in our research facility in Groningen for 5 days (4 nights). The follow up appointment will take place between the 18th and 22nd of March 2019.
Group 2: This group consists of 1 period during which you will stay in our research facility in Groningen for 12 days (11 nights). Depending on the radioactivity levels, there is a possibility that you may be required to come back for additional one to four 24-hours visits (1 overnight stay). The follow up appointment will take place on the 25th of March 2019 or 7 days after the last 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.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 3 months between the follow up in the previous study and the dosing in this study.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
Acromegaly is a rare disease where too much growth hormone is being produced. This causes hands, feet and facial features to grow in adults, or if it happens before or during puberty, it can result in extreme growth.
5 days stay
- 27 Feb 2019 up to and including 3 Mar 2019
12 days stay
- 4 Mar 2019 up to and including 15 Mar 2019
- 18 Mar 2019 up to and including 19 Mar 2019
- 25 Mar 2019 up to and including 26 Mar 2019
- 1 Apr 2019 up to and including 2 Apr 2019
- 15 Apr 2019 up to and including 16 Apr 2019