Group 1a
- 10 June up to and including 12 July
Period(s) of stay (33 days)
- 10 June up to and including 12 July
- 14 July
- 5 August
- 29 August
Visit(s)
- 14 July
- 5 August
- 29 August
- 19 September
Follow-up
- 19 September
- €9679,-
Compensation
- €9679,-
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.
- In part 1, an lumbar puncture will be administered at 3 different times.
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.
The study consists of two parts: Part 1 and Part 2. You can only participate in one group of one part. In both parts you will be given the compound as a drink of 20 milliliters. In Part 1, the study compound will be tested at various dose levels. In this part we compare the effects of the study compound with the effects of placebo (a compound without any active ingredient). 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.
In all groups of Part 1, cerebrospinal fluid will be collected from you at 3 different times during the stay through a lumbar puncture. This involves inserting a thin needle between two vertebrae in the lower back. This procedure is not entirely without risk. Collecting this fluid is important because it provides an indication of the levels of the investigational drug and its possible effects in the brain before and after each dose of the drug. The lumbar puncture will be performed by an experienced specialist.
To see if we can properly collect this cerebrospinal fluid from you, an MRI scan will be done at a second visit as part of the screening visit.
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
You will receive a gross compensation of € 9679 for full participation in group 1 of Part 1. You will receive a gross compensation of € 6641 for full participation in group 2 and all groups of Part 1 that come after group 1.
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
Group 1 of Part 1 consists of 1 period during which you will stay at the research center in Groningen for 33 days (32 nights), followed by 4 short visits. The follow-up visit will take place during the last short visit. As part of the screening, there will also be a separate visit for an MRI scan.
Group 2 and the groups thereafter of Part 1 consist of 1 period during which you will stay at the research center in Groningen for 19 days (18 nights), followed by 4 short visits. The follow-up visit will take place during the last short visit. As part of the screening, there will also be a separate visit for an MRI scan.
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. The current dates of the clinical trial will be published on our website. The location in Groningen is Van Swietenlaan 6.
Explanation video
MORE INFORMATION ABOUT A LUMBAR PUNCTURE
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!
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We pay the compensation for your participation, including travel expenses, within 21 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.