Study groups
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
In this clinical trial, we look how the study compound in combination with 2 approved medicines is processed and excreted by the body. The approved medicines are called digoxin and rosuvastatin, and are already available on the market. Digoxin is used for the treatment of heart failure, and rosuvastatin for high cholesterol. In addition, it is investigated how well healthy participants tolerate the study compound in combination with both approved medicines.
Who can participate?
As a male there are no contraception methods required to participate.
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
Note:
You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the last dosing). 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??
You will receive a gross compensation of € 5552 for participation in this study.
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 van Swietenlaan 6) for 24 days (23 nights). The follow-up visit will take place 6 to 10 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. The current dates of the clinical trial will be published on our website.
The study compound has been administered to humans before in 16 completed drug studies with 412 subjects. The following side effects are most often observed: gastrointestinal events (nausea, vomiting and diarrhea), headache and dizziness. You should take into account that unknown side effects may occur during the study. The study compound will be administered once daily for 15 days, as a tablet (by mouth). In addition, you will receive both digoxin, and rosuvastatin on day 1 and day 14 (a total of 2 times) as a tablet (by mouth).
Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
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.
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.