Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
In this study, it will be investigated how safe the new compound is and how well it is tolerated when it is used in healthy participants. It will also be investigated how quickly and to what extent the new compound is transported and eliminated from the body.
During this study, a PICC-line (peripherally inserted central venous catheter) will be used to administer the compound in a vein. The PICC-line is used as a new method of administration. Read more about this procedure below at "Other information".
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?
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
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 1 period during which you will stay in the research facility in Groningen (location Hanzeplein 1) for 17 days (16 nights), followed by 1 short visit. The follow-up visit will take place 6 to 10 days after your short visit in the research facility.
Note: You must be available for all dates to be able to participate in this clinical trial.
During this study, a PICC-line (peripherally inserted central venous catheter) will be used to administer the compound in a vein. The PICC-line is used as a new method of administration. The tolerability of the compound is being investigated in this study with this method of administration. The PICC-line will be placed prior to dosing and will remain for 13 days. A PICC-line is a catheter (a flexible tube) that is placed in the vein of the upper arm. The placement will be done after you have received a local anaesthetic. This can cause some discomfort for a day or two. A PICC-line is regularly used in healthcare, mainly to prevent repeated blood draws from the vein. People with a PICC-line can continue their daily activities.
Your heart rhythm will be continuously monitored for approximately 48 hours at two 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 anymore. The use of a phone or laptop is allowed. At certain time-points you will be asked to remain lying down for 15 minutes without moving, talking or sleeping.
To participate in this trial you must be willing to give a blood sample for genetic testing (DNA testing).
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.
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.
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).