• The study compound is being developed for the treatment of diabetes type 2 and has been administered to healthy people before in a previous clinical trial. In type 2 diabetes, too much sugar remains in the blood because the body no longer responds properly to insulin. Insulin is the hormone that regulates blood sugar levels.
• In this study we investigate whether approved compounds that are already available on the market (itraconazole, gemfibrozil, and cyclosporine) have an influence on the way the  study compound is processed and eliminated by the body and how well the combination of the study compound and the other compounds is tolerated when it is used by healthy participants. Itraconazole is used to treat fungal infections, gemfibrozil is used to treat high cholesterol, and cyclosporine is used to treat psoriasis.
• The trial consists of 2 parts:
• In part 1, you receive two times a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the first period you will receive a single dose of the study compound once. In the second period you will receive a single dose of the study compound once, and you will also receive itraconazole. This will also be administered in the form of a capsule to swallow. You will receive itraconazole once or twice daily for 12 days.
• In part 2, you receive four times a single dose of the study compound. This will be administered in the form of a capsule to swallow. In the first period you will receive a single dose of the study compound once. In the second period you will receive a single dose of the study compound once, and you will also receive gemfibrozil in the form of a tablet to swallow. You will receive gemfibrozil twice daily for 5 days. In the third and fourth period you will receive a single dose of the study compound once, and you will also receive cyclosporine in the form of a capsule to swallow. You will receive cyclosporine once in both period three and four.
• Only for part 2: Based on the results of the first 2 periods, it could be decided period 3, and/or period 4 will not take place.

• 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 and at most 32 kg/m2. 
• Both non-smokers and light or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). During your stay in our research facility you are not allowed to smoke.
• As a female you can only participate if you are not pregnant, not breast feeding 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 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) and you use a condom;
    • You are not sexually active according to your lifestyle;
    • You are only sexually active with a partner of the same sex.

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). This might 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.

The trial consists of 2 parts: part 1 and part 2. You can only participate in one group of this trial.

Part 1 consists of 2 periods during which you will stay each period in the research facility in Groningen (location van Swietenlaan 6). The first period you will stay in the research facility for 6 days (5 nights), followed by one short visit. The second period you will stay in the research facility for 14 days (13 nights), followed by 3 short visits. The follow-up visit will take place 4 to 8 days after your last short visit.

Part 2 consists of 4 periods during which you will stay each period in the research facility in Groningen (location van Swietenlaan 6). The first period you will stay in the research facility for 6 days (5 nights), followed by one short visit. The second period you will stay in the research facility for 8 days (7 nights), followed by 1 short visit. The third period you will stay in the research facility for 6 days (5 nights), followed by 1 short visit. The fourth period you will stay in the research facility for 6 days (5 nights), followed by 1 short visit. The follow-up visit will take place 9 to 13 days after your last short visit.

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.