Group 4
- 7 up to and including 30 May
Period(s) of stay (24 days)
- 7 up to and including 30 May
- €5552,-
Compensation
- €5552,-
Follow up on the 03rd or 04th of June 2024
Follow up
Follow up on the 03rd or 04th of June 2024
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 45 kg
- Your Body Mass Index (BMI) is between 18 and 30.9 kg/m2
Good to know about this trial
- This clinical trial partly takes place in Groningen and Utrecht
- The study compound has previously been administered to humans
Study groups
Register without obligation for the group of your preference
The research physician about this research
Additional information
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. You receive the compound once. The clinical trial consist of 4 parts:
- In part 1, you receive only the study compound, as a capsule for swallowing.
- In part 2, you receive the study compound, as a capsule for swallowing, in combination with Itraconazole. Itraconazole is already being used for the treatment of fungal infections, and will be administered as a capsule for swallowing.
- In part 3, you receive the study compound, as a capsule for swallowing, in combination with Fluvoxamine. Fluvoxamine is already being used for the treatment of anxiety and compulsive disorders, and will be administered as a tablet for swallowing.
- In part 4, you receive the study compound, as a capsule for swallowing, in combination with Paroxetine. Paroxetine is already being used for the treatment of depressions and anxiety disorders, and will be administered as a tablet for swallowing.
You can only participate in one group of this trial.
Download the research overview for part 2.
Who can participate in this trial?
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 for males, and 45 kg for females. Your Body Mass Index (BMI) is at least 18.0 and not higher than 30.9 kg/m2.
- Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 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 3 months prior to the first compound administration in this clinical trial (counting from the last dosing of the previous trial).
- 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.
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 or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
What is the compensation for this research?
Compensation
- Voor deelname in deel B krijg je een bruto vergoeding van €4467,-.
- Voor deelname in deel C krijg je een bruto vergoeding van €6203,-.
- Voor deelname in deel D krijg je een bruto vergoeding van €5552,-.
Reiskosten worden vergoed op basis van kilometers (€ 0,21 netto per kilometer) met een minimum van € 13,- en een maximum van € 176,40 (840 kilometer) per retour, ongeacht de wijze van vervoer.
Hoe lang duurt het onderzoek?
Periode onderzoek
Part 2: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 19 days (18 nights). The follow-up visit will take place 2 to 8 days after your departure from the research facility.
Part 3; The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 27 days (26 nights). The follow-up visit will take place 2 to 8 days after your departure from the research facility.
Part 4: 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 2 to 8 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.
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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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!