Download the complete research overview of part A
Study groups
The research physician about this research
All (possible) 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 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.
Who can participate?
Note: You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening in this clinical trial (counting from the follow-up visit of the previous trial).
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.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
For participation in part A or part C of the trial, you will receive a gross compensation of €1692.
For participation in part B of the trial, you will receive a gross compensation of €3253.
Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net 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: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 2 to 3 days after your departure from the research facility.
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 2 to 3 days after your departure from the research facility.
Part C: The trial consists of 2 periods during both of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 3 days (2 nights). The follow-up visit will take place 3 to 6 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 current dates of the clinical trial will be published on our website.
More information about the study
Soon a clinical trial will start at ICON with a new compound that may be used for the treatment of cardiometabolic diseases. Cardiometabolic diseases are a group of chronic diseases that can affect the cardiovascular system (heart and blood vessels) and the metabolic health (such as blood sugar, fat and energy balance in the body).
In this trial, we investigate how safe the new compound is and how well it is tolerated when it is administered to healthy participants. Furthermore, we investigate how the compound works in the body and what the body does to the compound. The trial consists of 3 parts, Part A, Part B and Part C. In Part A and Part B, we compare the effects of the compound with the effects of a placebo. A placebo is a compound without any active ingredient. In Part C we will look at the effect of food on the uptake of the study compound.
The compound has not been used by humans before. It has been extensively tested in the laboratory and on animals.
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) and the
Central Committee on Research Involving Human Subjects (CCMO).
For participation in one of the groups of Part A or Part C of the trial, you will receive a gross compensation of €1692.
For participation in one of the groups of Part B of the trial, you will receive a gross compensation of €3253.
Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net 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.
All potential medicines can cause side effects. As the compound will be administered to humans for the first time in this trial, side effects in humans are not known yet. The compound has been studied extensively in the laboratory and in animals.
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.
This trial will be executed in healthy male and female participants. The trial consists of 3 parts. You can participate in only one part of 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.
Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 2 to 3 days after your departure from the research facility.
You will receive the compound once in total. You will be given the compound or placebo which will have to be swallowed (with a glass of water). In some of the groups a large amount of the compound will be administered.
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 2 to 3 days after your departure from the research facility.
You will receive the compound for 7 days. You will be given the compound or placebo which will have to be swallowed (with a glass of water). In some of the groups a large amount of the compound will be administered.
Part C: The trial consists of 2 periods during both of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 3 days (2 nights). The follow-up visit will take place 3 to 6 days after your last departure from the research facility.
You will receive the compound once per period. The compound will have to be swallowed (with a glass of water). A large amount of the compound will be administered. You will receive the compound once following a breakfast and once without breakfast. The order in which this will occur will be determined beforehand by chance. The breakfast is a high-fat breakfast, which must be started exactly on time and must be finished within 20 minutes. The entire breakfast must be consumed, if you are unable to do so you cannot participate in this trial. The high-fat breakfast is a large breakfast of 2 fried eggs, fried potatoes, 2 slices of bread with margarine, 1 glass of whole milk and bacon or brie. It might be difficult for light eaters to consume the entire breakfast.
During the trial, blood will regularly be drawn and urine will be collected. After the screening it will be announced whether you can participate.
Consumption of medication is not allowed during the trial. Consumption of alcohol, coffee and tea, cola, power drinks and chocolate (inclduing chocolate milk), poppy seeds and tobacco/nicotine-containing products is not allowed during your stay at the research center, but may be allowed (in limited quantities) when you are not at the research center. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.
Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.
Je kunt tijdens het onderzoek last krijgen van bijwerkingen. Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.
Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.
Als je meedoet aan geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.