Multiple Sklerose (MS)

Important information about this study

• In part 1, the compound will be given both times after you have not eaten anything for at least 10 hours, including the night.
• In part 2, the compound will be given once after fasting overnight and once after the consumption of a meal.
• This order can also be inverted (fasting – meal consumption or meal consumption–fasting).

Who can participate?

• You are a healthy male or female.
• You are at least 18 and no more than 54 years old.
• Your Body Mass Index (BMI) is at least 18 and no more than 30 kg/m2. 
• Both non-smokers and light smokers or occasional smokers (up to a maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. Smoking is not allowed during your stay in our research facility.

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). For some trials this term will be 6 months, this will be discussed during your telephone screening. 
• For this trial, you cannot (have) receive(d) an influenza and/or COVID-19 vaccine within 6 weeks prior to the start and during this trial.
• 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. The medical screening consists of two separate visits. After the regular medical screening at ICON there will be an additional visit to perform an MRI scan.

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 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.