Eye condition caused by diabetes

Eye condition caused by diabetes

Clinical trial of a new compound that is being developed for the treatment of an eye condition caused by diabetes

The research physician about this research

This study consist of two parts, part 1 and part 2. You can only participate in one part. The study drug is given in the form of a tablet. In part 1 (groups: 1a, 1b, 1c, 1d en 1d), the purpose of the study is to investigate different formulations of the tablet and to assess the safety and tolerability of the study drug. In part 2 (groups: 2a en 2b), the effect of food on the study drug is examined both after a high-fat meal and without a meal.

Important information about this study

• The study drug has already been administered to healthy volunteer and was well tolerated.
• Both men and women can participate in this clinical trial
• During the study you will already receive a part of the compensation

Who can participate?

• You are a healthy male or female
• You are between 18 and 64 years old
• You weigh at least 50 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m2. 
• You do not smoke and do not use nicotine products.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening of this clinical trial (counting from the follow-up visit of the previous study). This might be 90 days 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 done in Groningen or Utrecht.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

• You use adequate contraception (for example the contraceptive pill or 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 not sexually active according to your lifestyle;
• You only have sexual contact with women.

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

• You use a condom in combination with an additional contraception method used by your female partner;
• You use a condom when your female partner is pregnant;
• You have been sterilized or your female partner has been sterilized or passed the menopause;
• You are not sexually active according to your lifestyle;
• You only have sexual contact with men.

Compensation

• You will receive a gross compensation of € 4028 for participation in this trial.

Travel expenses will be reimbursed based on the distance traveled (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, regardless of the mode of transportation.

Period of stays and research

• Both parts of the trial consist of 4 periods during which you will stay in the research facility in Groningen for 5 days (4 nights) each period, followed by 1 short visit per period.
• The follow-up visit will take place  9 to 13 days after your last departure from the research facility.

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