NO0009-1092-GRQ
Clinical trial of a new compound that is being developed for the treatment of heart and vascular disease and metabolic diseases
€1.503,-
A very positive experience. You are guided step by step throughout the process.
A very positive experience. You are guided step by step throughout the process.
Study groups
The research physician about this research
The study compound may potentially be used for the treatment of heart and vascular diseases and metabolic diseases. In metabolic diseases, something goes wrong with the conversion of nutrients into energy, or nutrients are not properly broken down. Heart and vascular diseases and metabolic diseases are a group of long-term diseases.
The clinical trial consists of five parts: Part A, Part B, Part C, Part D and Part E. You can only participate in one part. Below we describe Part A through D.
In all parts of this trial, we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body.
In Part A to D, we will investigate how safe the study compound is and how well it is tolerated. In Part B and C, we will look if the study compound has an effect on an important protein involved in inflammation. In Part D, we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body during fed or fasted conditions. In Part B, and C, we will compare the effects of the study compound with the effects of a placebo. A placebo is a compound without any active ingredient. In all the parts, you will be given the study compound (or placebo) as capsules by mouth with water.
In Part A and B, you will receive the study compound once.
In Part C, you will receive the study compound once daily for 28 days.
In Part D, you will receive the study compound twice.
During Part B and C, your heart will be monitored continuously from 18 hours before administration of the study compound until 54 hours (Part B) or (Part C) 24 hours thereafter. 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 10 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.
In Part D, you will receive the study compound once with a breakfast and once without breakfast. The order in which this will occur will be determined by chance. In one period you will receive a high-fat breakfast with a standard composition. You must start it exactly on time and finish it within 20 minutes. The entire breakfast must be consumed.
To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht. During the screening, you will have to undergo a swallowing test. This is to determine whether you are able and willing to swallow a large number of capsules and tablets. 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 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.
The compound has already been tested in healthy individuals. In these clinical trials, the following side-effects were observed most often: headache. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. 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 questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. 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.
Who can participate?
What is the compensation for this research?
You will receive a gross compensation of € 1.503,- for participation in Part A.
You will receive a gross compensation of € 1.973,- for participation in Part B.
You will receive a gross compensation of € 7.445,- for participation in Part C.
You will receive a gross compensation of € 3.199,- for participation in Part D.
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 4 to 6 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 6 days (5 nights), followed by 1 short visit. The follow-up visit will take place 9 days after your departure from the research facility.
Part C of the trial consists of 1 period during which you will stay in the research facility in Groningen for 30 days (29 nights), followed by 1 short visit. The follow-up visit will take place 12 days after your departure from the research facility.
Part D of the trial consists of 2 periods during which you will stay in the research facility in Groningen for 6 days (5 nights) per period. The follow-up visit will take place 4 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. 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.