Neuromuskuläre Erkrankungen

Die Studie

Clinical trial of a new compound that is being developed for the treatment of neuromuscular diseases.

• You are a healthy male or female.
• You are between 18 and 65 years old.
• Your weight is between 50 kg and 100 kg and your Body Mass Index (BMI) is between 18.0 and 30.5 kg/m2. 
• Only non-smokers are allowed to participate in this clinical trial.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 3 months prior to the first compound administration in this clinical trial (counting from the last compound administration).
• To determine if you are suitable to participate in this trial, you will undergo a medical screening including physical exam and laboratory tests. Depending on availability, this can be performed in Groningen or in Utrecht.

As a female you can only participate if you meet one of the following conditions:

• You have passed the menopause (no periods for at least 12 months);
• You have been sterilized;

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.

Zeitraum

The trial consists of 2 parts: part A and part B. You can participate in one part of the trial.

• Part A of the trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 9 days (8 nights), followed by 9 short visits. The short visits will be spread out over a 5 month period. The follow-up visit will take place during your last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial.

Aufwandsentschädigung

• You will receive a gross compensation of € 7403 for participation in one of the groups of part B.

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.