Group 2.2a
- 14 up to and including 28 April
Period(s) of stay (15 days)
- 14 up to and including 28 April
- 30 April
Visit(s)
- 30 April
- €3828,-
Compensation
- €3828,-
On appointment on 06 May 2025
Follow-up
On appointment on 06 May 2025
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 64 years old
- You weigh more than 50 kg
- Your Body Mass Index (BMI) is between 18.5 and 29.5 kg/m2
Good to know about this trial
- Light smokers can participate in this clinical trial
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
- The new compound is being developed for the treatment of Parkinson's disease.
- The new compound will be administered to humans for the first time in this trial.
- The trial consists of 3 parts: part 1a, part 1b and part 2. You can only participate once.
- In part 1b and part 2, the compound is administered multiple times as capsules via the mouth.
- In part 1a and part 2 of the trial, your heart rate will constantly be monitored at certain times for 24 or 48 hours. For this you will have stickers (electrodes) on your chest that are attached to a device. If you are connected to this device, you cannot shower, and you must behave as calmly as possible. Occasionally you will even have to lie still for 15 minutes without moving, talking, or sleeping. You will also not be able to listen to music, watch TV or use a laptop or telephone then.
who can participate?
Target group
- You are a healthy male or female.
- Part 1b: You are at least 18 and at most 55 years old.
- Part 2: You are at least 18 and at most 64 years old.
- Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.5 kg/m2.
- Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 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 the 90 days prior to the first compound administration in this clinical trial (counting from the follow-up visit). This may be longer for certain trials, please contact us for further information.
- 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 are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones) in combination with a condom;
- You are using a copper intra-uterine device in combination with a condom;
- You have passed the menopause (no periods for at least 12 months);
- You have been sterilized or your male partner has been sterilized;
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
- As a male you can only participate if you meet one of the following conditions:
- You are using a condom during intercourse with a fertile 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 the research?
Compensation
- For participation in one of the groups of part 1b of the trial, you will receive a gross compensation of € 3201.
- For participation in one of the groups of part 2 of the trial, you will receive a gross compensation of € 3828.
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
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Part 1b: The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights). Each period is followed by 2 short visits. The follow-up will take place during the final short visit.
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Part 2: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 15 days (14 nights), followed by 1 short visit. The follow-up visit will take place 1 – 5 days after the short visit.
Note: You must be available for all dates to be able to participate in this clinical trial.
Veelgestelde vragen
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Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.
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Je kunt tijdens het onderzoek last krijgen van bijwerkingen. Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.
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Als je meedoet aan geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.
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Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.