Download the complete research overview of part B.
Study groups
The research physician about this research
The study compound is being developed for the treatment of heart failure. In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.
Who can participate?
Note:
As a female you can only participate if you meet one of the following conditions:
As a male you can only participate if you meet one of the following conditions;
What is the compensation for this research?
For participation in one of the groups of part B of the trial, you will receive a gross compensation of €3199.
Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.
How long does this research take?
The trial consists of 4 parts: part A, part B, part C and part D. You can only participate in one part of this clinical trial.
Part B consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days (about 3 and a half weeks) after the follow-up visit, you will be contacted by phone for some questions.
Note: You must be available for all dates to be able to participate in this clinical trial.
The trial consists of 4 parts: part A, part B, part C and part D.
In part B you receive the compound once or twice daily for 10 days (about 1 and a half weeks).
Besides the set moments for the research, you have a lot of time for yourself. The research centers offer wireless internet, TVs with a DVD or Blue-ray player or Netflix, as well as computers and video game consoles in the living room. You can also play darts, pool and table tennis. Some participants really take this time for themselves. They study or read a book. During longer studies, ICON organizes activities and workshops.
You may take part in four studies per year. There must be a period of at least 30 days between each study. A longer waiting time applies for some studies.
During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.
Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.
ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.