Group 2a (part 2)
- 1 up to and including 21 December
Period(s) of stay (21 days)
- 1 up to and including 21 December
- 4 January
- 27 January
Visit(s)
- 4 January
- 27 January
- 28 February
Follow-up
- 28 February
- €5530,-
Compensation
- €5530,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 64 years old
- Your Body Mass Index (BMI) is between 18.5 and 30 kg/m2
Good to know about this trial
- You will receive the compound as a drink.
- The 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
Multiple sclerosis (MS) is a chronic disease in which inflammation develops in the central nervous system (brain and spinal cord). In MS, this central nervous system cannot process certain signals properly because the protective coating on nerve cells (called myelin) is damaged. The aim of this study compound is to slow down the development of disabilities that MS can cause and to improve the functioning of the nervous system.
The purpose of this study is to investigate how quickly and to what extent the study compound is taken up, modified, distributed, and removed from the body. We will also look at the effects of the study compound in the body.
In Part 2, you will be given the approved drug itraconazole in addition to the study compound. The study compound has been used by humans before in four clinical trials. It has also been extensively tested in the laboratory and on animals.
Who can participate in this trial?
Target group
- You are a healthy male or female.
- You are at least 18 and no more than 64 years old.
- Your Body Mass Index (BMI) is higher than or equal to 18.5 and lower than or equal to 30.0 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
- 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 center and two days prior to the administration of the study compound 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 of the previous trial). This may be shorter or longer in certain trials, please contact us for more 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 breastfeeding 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 only sexually active with a partner of the same sex;
- You are not sexually active according to your lifestyle.
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 are using a condom with a pregnant 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 only sexually active with a partner of the same sex;
- You are not sexually active according to your lifestyle.
WHAT IS THE COMPENSATION FOR THIS RESEARCH
Compensation
For full participation in one of the groups of Part 2 of the trial, you will receive a gross compensation of € 5530.
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
Trial Period
Part 2 of the trial consists of 1 period during which you will stay at the research center in Groningen for 21 days (20 nights), followed by 3 short visits. The follow-up visit will take place during the last short visit.
Note: You must be available for all dates to be able to participate in this clinical trial.
Veelgestelde vragen
-
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.
-
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.
-
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!
-
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.