Group A4a
- 29 August up to and including 2 September
Period(s) of stay (5 days)
- 29 August up to and including 2 September
- €1375,-
Compensation
- €1375,-
op afspraak tussen 3 sep 2023 t/m 6 sep 2023
Nakauring
op afspraak tussen 3 sep 2023 t/m 6 sep 2023
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 65 years old
- Your Body Mass Index (BMI) is between 19 and 28 kg/m2
- Non-smoker
Good to know about this trial
- The medical screening will take place in Groningen or Utrecht
- This is a clinical trial with a short stay of just 4 nights.
- Your travel expences will be reimbursed with a maximum of € 176.40.
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
In this clinical trial we will investigate how safe the study compound is and how well this is tolerated when it is used by healthy participants. The trial is divided into two parts: part A and part B. There will be several groups in each part. You can only participate in one group in one part.
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 in this trial?
Target group
- You are a healthy male or female.
- You are at least 18 and at most 65 years old.
- Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 19.0 and at most 28.0 kg/m2.
- You do not smoke and do not use any nicotine-containing products.
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 administration).
- For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the start of this trial until the follow-up visit.
- 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.
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
- You have passed the menopause (no periods for at least 12 months);
- You have been sterilized (at least 6 months ago).
As a male you can only participate if you meet one of the following conditions:
- You are using a condom in combination with an additional contraception method used by your female partner;
- You have been sterilized;
- Your female partner is sterilized or has passed the menopause (no periods for at least 12 months) and you are using a condom;
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex and you are using a condom.
The compensation for this trial
Compensation
- You will receive a gross compensation of € 1375 for participation in one of the groups of part A.
- For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 4312.
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 will the trial take?
Period of stay
- Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). The follow-up visit will take place 1 – 4 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 18 days (17 nights). Two follow-up visits will follow: the first follow-up visit will take place 3 – 7 days after your departure from the research facility. The second follow-up visit will take place 13 – 17 days after you departure from the research facility.
Note: You must be available for the whole period of Part A or Part B to be able to participate in this clinical trial.
Frequently asked questions
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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.
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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.
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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.
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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).