Group A1a
- 13 up to and including 19 December
Period(s) of stay (7 days)
- 13 up to and including 19 December
- 12 January (phone call)
Follow-up
- 12 January (phone call)
- €1668,-
Compensation
- €1668,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 55 years old
- You weigh more than 50 kg
- Your Body Mass Index (BMI) is between 18.5 and 32 kg/m2
Good to know about this trial
- Within this cinical trial interrem payment is possible.
- The medication will be given in the form of a capsule for swallowing.
- Smokers can participate in this research.
Download the complete research overview of part A.
Download the complete research overview of part B.
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
The study compound is being developed for the treatment of heart failure. In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.
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?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 55 years old.
- Your weight is at least 50 kg
- Your Body Mass Index (BMI) is:
- at least 18 and at most 32 kg/m2 for part A, B and C.
- at least 18 and at most 30 kg/m2 for part D.
- Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 4 cigarettes per day). During your stay in our research facility, you are not allowed to smoke.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days (about 4 and a half weeks) prior to the screening of 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.
As a female you can only participate if you meet one of the following conditions:
- You have passed menopause (no periods for at least 12 months);
- You have been sterilized or due to other reasons are sterile.
As a male you can only participate if you meet one of the following conditions;
- You are using a condom during sexual intercourse;
- You are not sexually active according to your lifestyle.
What is the compensation for this research?
Compensation
For participation in one of the groups of part A of the trial, you will receive a gross compensation of €1668.
For participation in one of the groups of part B of the trial, you will receive a gross compensation of €3199.
For participation in one of the groups of part C of the trial, you will receive a gross compensation of €3850.
For participation in one of the groups of part D of the trial, you will receive a gross compensation of €4718.
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?
Period of stay and research
The trial consists of 4 parts: part A, part B, part C and part D. You can only participate in one part of this clinical trial.
Part A consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up visit will take place on the day of your departure from the research facility. 21 to 27 days (about 4 weeks) after your departure from the research facility, you will be contacted by phone for some questions.
Part B 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 to 5 days after your departure from the research facility. 20 to 26 days (about 3 and a half weeks) after the follow-up visit, you will be contacted by phone for some questions.
Part C consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 16 days (15 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days (about 3 and a half weeks) after the follow-up visit, you will be contacted by phone for some questions.
Part D consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 20 days (19 nights). The follow-up visit will take place 3 to 4 days after your departure from the research facility. 21 to 27 days (about 4 weeks) after the follow-up visit, you will be contacted by phone for some questions.
Note: You must be available for all dates to be able to participate in this clinical trial.
Particularities
The trial consists of 4 parts: part A, part B, part C and part D.
In part A you receive the compound once.
In part B you receive the compound once or twice daily for 10 days (about 1 and a half weeks).
In part C you receive the compound twice daily for 14 days (about 2 weeks).
In part D you receive the compound twice in combination with an approved medicine.
- For part A, part B and part D: During the trial your heart rhythm and blood pressure will be continuously monitored during certain periods.
- For all parts: on some days, during the trial, you have to fast up to 14 hours.
Frequently asked questions
-
Besides the set moments for the research, you have a lot of time for yourself. The research centers offer wireless internet, TVs with a DVD or Blue-ray player or Netflix, as well as computers and video game consoles in the living room. You can also play darts, pool and table tennis. Some participants really take this time for themselves. They study or read a book. During longer studies, ICON organizes activities and workshops.
-
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.
-
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.