Study groups
The research physician about this research
In this clinical trial we will investigate how safe the study compound is and how well this is tolerated when it is used by healthy participants. The trial is divided into part A and part B and each part consists of multiple groups. In part A, there is one group in which the effect of food on the study compound will be investigated. You can only participate in one group in one part.
All (potential) medicines can cause side effects. In this trial, the new compound is tested in humans for the first time. At this point, a large part of the trial has already been completed.
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 and side effects observed in completed groups. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. 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.
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 are not pregnant, not breast feeding and meet one of the following conditions, from 4 weeks prior to the first compound administration in this trial:
As a male you can only participate if you meet one of the following conditions:
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
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?
Part B (group B5): The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 24 days (23 nights). The follow-up visit will be a 24-hour visit (1 overnight stay) and will take place 4 – 6 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.
Read more about the research
Soon a clinical trial will start at ICON with a compound that may potentially be used for the treatment of atrial fibrillation. Atrial fibrillation is a common heart rhythm disorder with a rapid, non-regular heartbeat. In this trial, we investigate how safe the new compound is and how well it is tolerated when it is administered to healthy participants.
We will also investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. In addition, we look at the effect of food on the absorption of the study compound.
We will compare the effects of the new compound with the effects of a placebo. A placebo is a compound without any active ingredient. The compound has not been administered to humans before. It has been extensively tested in the laboratory and on animals. The study compound will be tested at various dose levels.
This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Independent Ethics Committee (METC).
This trial will be executed in healthy male and female participants. The trial consists of 2 parts. You can participate only once in this trial. To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial. You will be given the study compound as oral tablets with 240 milliliters (mL) of (tap) water.
Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). The follow-up visit will take place 3 – 5 days after your departure from the research facility. The study compound will be administered once.
Part A (food effect group): The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). The follow-up visit will take place 3 – 5 days after your departure from the research facility after the last period. The subjects in this group will receive the study compound once without breakfast (Period 1) and once with a breakfast (Period 2). You will receive a high-fat breakfast with a standard composition, which must be started exactly on time and must be finished within 20 minutes. The high-fat breakfast is a large breakfast, including 2 fried eggs, fried potatoes and bacon or cheese. It can be difficult to consume the entire breakfast, for light eaters.
Part B: The trial 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 – 6 days after your departure from the research facility. The study compound will be administered once or twice a day for 10 days.
During the trial, blood will regularly be drawn and urine will be collected. Prior to screening and (each) admission, you have to stay fasted for 4 hours. Prior to the follow-up, you have to stay fasted for 10 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.
Consumption of medication, alcohol, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including juice) and tobacco / nicotine containing products are not allowed during the trial. Also, before the start of the trial and when you are not staying in the research facility, there could be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.
All potential medicines can cause side effects. As the study compound will be administered to humans for the first time in this study, side effects of the compound in humans are not known yet. The study compound has been studied extensively in the laboratory and in animals. Based on the way this study compound works and studies in animals, the following side effects may be seen:
Blood pressure: Studies in animals have shown that het study compound may cause an increase in blood pressure. However, studies looking at human genes and human studies with another drug that works in a similar way have not shown a risk of increased blood pressure.
Brain effects: For the study compound, signs of tremors and unsteadiness that came and went were seen in dogs at high doses, but not in rats. In human studies with another drug that works in a similar way, no tremors or other brain effects were seen.
Disturbances of the heart rhythm: Many drugs that block heart-related ion channels can increase the risk of certain heart rhythm problems. Studies in animals and cells indicate that the study compound has a low risk of causing this. In human studies with another drug that works in a similar way, no heart rhythm problems were seen.
You should take into account that (serious) side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation. During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.
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.
Unfortunately, not all side effects of a drug can be predicted. However, doctors can estimate which side effects will occur based on previous research. During the study, the doctors and nurses carefully monitor participants.
No. The amount of compensation for participating in a trial is based on the length of the trial. The longer the trial lasts and the more times you need to come back in, the higher the compensation. The compensation is provided to reimburse you for your time as a participant. The Medical Research Ethics Committee (MREC) ensures that the compensation is reasonably proportionate to the time you spend as a participant.