Group 3a
- 24 February up to and including 4 March
- 10 up to and including 18 March
Period(s) of stay (18 days)
- 24 February up to and including 4 March
- 10 up to and including 18 March
- 25 March
Follow-up
- 25 March
- €4368,-
Compensation
- €4368,-
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 and 29.5 kg/m2
Good to know about this trial
- The study compound has been administered to humans before and was well tolerated.
- As a smoker (max. 10 sigarettes a day) you can also participate.
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
- The study compound is intended for the treatment of inflammatory diseases. Inflammatory diseases are conditions in which the body's immune system has a long lasting or excessive response to injury, infection, or irritation, leading to tissue damage rather than healing. These diseases can affect various parts of the body and lead to a lot of symptoms depending on the specific condition and the organs involved. Examples of inflammatory diseases are: rheumatoid arthritis and bowel diseases like Crohn’s disease and ulcerative colitis.
- In this study we will investigate how safe the new compound is and how well it is tolerated when it is used by healthy subjects. We also investigate how quickly and to what extent the new compound is absorbed, transported, and eliminated by the body. During the study, blood and urine will be collected to check lab values and to look at the amount of the study compound in the blood per day.
- The study consists of part 1, part 2 and part 3. Part 1 and 2 have been completed. You can participate in part 3 of this trial.
- In part 3 of the study the study compound will be taken in by mouth: once following a low-fat breakfast and once following a high-fat breakfast to see if this changes the uptake of the study compound.
- During your medical screening a swallowing test will be done during which you will be asked to take a number of empty capsules with a glass of water. The swallowing test is performed because it is known that the size of the capsules is relatively large (capsule with a size of 19.7 × 7.2 mm).
- The compound has already been tested in healthy individuals. In these clinical trials, the following side-effects were observed most often: headache, diarrhea and irritation from medical equipment. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. Once everything is clear to you, you can decide to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.
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 and your Body Mass Index (BMI) is at least 18.0 and at most 29.5 kg/m2.
- Both non-smokers and smokers (maximum of 10 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.
- 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 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.
Note:
- You cannot participate in the trial if you have participated in another clinical trial within 1 month prior to the first compound administration in this clinical trial (counting from the last follow-up visit of the previous trial). For participation in certain previous trials this time period can also be 3 months, please contact us to see if this is applicable for you. You cannot participate in part 3 of this study if you participated in part 1 or 2 previously or if you participated in trials with the same compound.
- 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?
Compensation
For participation in part 3 of the trial, you will receive a gross compensation of € 4368.
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
Part 3 of the trial consists of 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights) in each period. The follow-up visit will take place 7 days after your departure from the research facility in period 2.
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 milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.
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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Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!
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Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.