Die Studie
Arzneimittelstudie zu einem neuen Medikament, das zur Behandlung von Multiple Sklerose.
- 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.
Zeitraum
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.
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.
Aufwandsentschädigung
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.
