Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
This clinical trial examines how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
From 18 hours before dosing until 36 hours after, your heart will be monitored constantly (i.e. for 54 hours). For this purpose, you will receive pads (electrodes) on your chest that are attached to a device. As long as you are connected to this device, you cannot shower and must behave as calmly as possible. Occasionally you will have to lie still for 15 minutes without moving, talking or sleeping. Also, you cannot then listen to music, watch TV or use a laptop or phone.
The effects of the study compound are compared with the effects of a placebo (compound without active substance). Whether you receive the study compound or placebo is determined by lot.
You can only participate in one group of this trial.
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 there are no contraception methods required to participate.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
You will receive a gross compensation of € 1875 for participation in one of the groups of this trial.
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 study consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights), followed by 1 short visit which takes place 2 days after your departure from the research facility. The follow-up visit will take place 7 days after your last departure from the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.
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.
Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!