In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body.
Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body.
The trial consists of three parts: part A, part B and part C. In part A you will receive the new compound once. One group in part A will consist of two periods where you receive the new compound once each period. The effect of food on this new compound will be investigated in this group. In part B you will receive the new compound once daily for 10 days. In part C we investigate whether approved compounds that are already available on the market (rosuvastatin, furosemide, midazolam, flurbiprofen and repaglinide) have an influence on the way the new compound is processed and eliminated by the body. This part will consist of two periods where you will receive the new compound once daily for 10 days in the second period.
Only for part A and B: During the trial your heart rhythm will be monitored for approximately 25 hours at one (part A) or two (part A food effect and part B) different moments. You will be given electrodes (small, plastic patches) on your chest and abdomen that are connected to a portable device. As soon as you are connected, you cannot use electric devices (razor, electric toothbrush, hairdryer) for the duration of the heart monitoring. The use of a phone or laptop is allowed, except for the moments you need to lay down. At certain time-points you will be asked to remain lying down for 15 minutes without moving, talking or sleeping.
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 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?
The trial consists of three parts: part A, part B and part C. You can only participate (in one group of) one part in this trial.
Part A: This part 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 5 to 7 days after your departure from the research facility.
Part A food effect: This group consists of 2 periods during which each period 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 5 to 7 days after your last departure from the research facility.
Part B: This part consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 15 days (14 nights). The follow-up visit will take place 5 to 7 days after your departure from the research facility.
Part C: This part consists of 2 periods during which you will stay each period in the research facility in Groningen (location van Swietenlaan 6). The first period you will stay in the research facility for 6 days (5 nights). The second period you will stay in the research facility for 15 days (14 nights). The follow-up visit will take place 5 to 7 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.
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.
A trial usually involves 5 to 12 participants. The groups are set up so they best match the requirements of the trial. These requirements are described for each trial. View all current trials.
ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.