• Multiple sclerosis (MS) is a disease in which inflammation occurs in the central nervous system (brain and spinal cord). The condition cannot currently be cured. The central nervous system cannot process certain signals properly because the protective coating on nerve cells (called myelin) is damaged. The compound we are testing in this trial could slow down the development of the limitations that MS can cause and could improve the functioning of the nervous system. Depending on the location of the inflammation, MS patients have symptoms such as fatigue, problems with movement (muscle weakness), difficulty concentrating and intestinal complaints.
• The trial consists of 2 parts, part A and part B. Whether part B will be conducted depends on the results obtained in Part A. You can only participate once in this trial.
• In both parts, you will first receive only the study compound to determine its effect on the body. After this you will receive daily doses of a compound that is already available on the market, and during these daily doses you will receive one more dose of the study compound. The effect of the study compound when given by itself will be compared with the effect when given together with the compound already available on the market.

The study compound has already been tested in healthy individuals. In these clinical trials, the following side-effects were observed most often: the common cold, flatulence and a high concentration of hemoglobin (the part of your blood that carries oxygen) in urine, which can cause discoloration of the urine. 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.

• You are a healthy male or female.
• You are at least 18 and at most 65 years old.
• Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
• You do not smoke and do not use any nicotine-containing products.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up in the previous trial). This may be longer for 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 breast feeding and meet one of the following conditions:

• device containing hormones) for at least 1 month prior to the first compound administration in combination with a condom ;
• You are using a copper intra-uterine device;
• 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 use a condom during intercourse with a fertile 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.

Part A: The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). After period 1 you will receive medication to take at home twice daily for 5 days, and you will have 1 short visit to the research facility. After this you will return to the research facility for period 2. The follow-up will be via a telephone call.

Part B: The trial consists of 2 periods during each of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 8 days (7 nights). After period 1 you will receive medication to take at home daily for 10 days, and you will have 1 short visit to the research facility. After this you will return to the research facility for period 2. The follow-up will be via a telephone call.

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.