AR4973-0041-GRQ
Clinical trial of a study compound that is being developed for the treatment of skin conditions.
€1.503,-
It was a fantastic experience and the staff was friendly
It was a fantastic experience and the staff was friendly
Study groups
The research physician about this research
The study compound is being studied to determine whether it can be used for the treatment of chronic spontaneous urticaria (CSU) and atopic dermatitis (eczema). CSU is a common and distressing skin condition. It causes red, raised, itchy and sometimes painful rash or patches (hives or wheals) on the skin with no known obvious cause. Atopic dermatitis (eczema) is a condition that causes dry, itchy and inflamed skin.
In this trial we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy participants. We will measure the amount of the study compound in blood and urine. We will also measure how the study compound is broken down or changed in the body.
We will compare the effects of the study compound with the effects of a placebo. A placebo is a substance that looks like the study drug but does not contain an active ingredient. You will be given the study compound or placebo as capsules by mouth. In Part A, you will receive the study compound or placebo once. In Part B, you will receive the study compound once daily for 7 days. You can participate in one part of the study.
During the trial, your heart will be monitored continuously once (Part A) or twice (Part B). Each time, this will take place from 30 minutes before administration of the study drug until 24 hours afterwards. You will have sticky patches (electrodes) attached to your chest that are connected to a device. At various times, you will have to lie still for 15 minutes without moving, talking or sleeping. You also cannot listen to music, watch TV or use a laptop or phone. However, apart from these times, you may do so.
All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any question you may have. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
Prior to screening you have to stay fasted for 4 hours. You can only drink water prior to your visit. This means that we will ask you to fast (not to eat) prior to any participation in the trial. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.
Who can participate?
Note:
What is the compensation for this research?
You will receive a gross compensation of € 1.503,- for participation in Part A. For participation in Part B of the trial, you will receive a gross compensation of € 2.643,-.
Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.
How long does this research take?
Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen for 5 days (4 nights). The follow-up visit will take place between 11 to 18 days after your departure from the research facility.
Part B of the trial consists of 1 period during which you will stay in the research facility in Groningen for 10 days (9 nights). The follow-up visit will take place between 13 to 20 days after your departure from the research facility.
Note:You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website. The location in Groningen is Van Swietenlaan 6.
If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).
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.
The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.
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.