The study compound may potentially be used for the treatment of type 1 diabetes (diabetes mellitus). Diabetes is a condition where the body struggles to control sugar levels in the blood. People with type 1 diabetes need insulin because their body does not make it anymore. Insulin is a hormone that helps control the level of sugar in your blood. The study compound works by adjusting the activity of two hormones that are important for digesting food. The idea behind this is that it can help control blood sugar levels, slow digestion and reduce hunger.

In this study, we will look at the possible interaction between the study compound and the approved drug pitavastatin. We do this by investigating the effect of the study compound on how quickly and to what extent pitavastatin is absorbed, transported and eliminated from the body. Both of these compounds will be administered in this study. In addition, we will investigate the absorption, transportation, and elimination of the study compound in the body. We will also investigate how safe the study compound is and how well it is tolerated when it is used by healthy people.

During the study, you will be given the study compound once daily as an injection under the skin (subcutaneous), with increasing doses every 5 days. In total, you will be given pitavastatin three times as a tablet to be taken by mouth. You will also receive paracetamol in the form of a drink twice. This is done to test the rate at which, for example, simultaneously administered medication leaves the stomach and enters the small intestine.

During the study, your heart will be monitored continuously for more than 24 hours around two administrations. For this purpose, you will have stickers (electrodes) placed on your chest that are connected to a small device. At various times, you will have to lie still for 15 minutes without moving, talking, or sleeping. You will also not be able to listen to music, watch TV, or use a laptop or phone. Outside of these moments, you are allowed to do so.

The compound has already been tested in healthy individuals and patients with type 1 and 2 diabetes. In these clinical trials, the following side-effects were observed most often: nausea, diarrhea, vomiting, abdominal pain and constipation (difficulty passing stool). 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 55 kg and your Body Mass Index (BMI) is at least 25.0 and at most 45.0 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• Both non-smokers and smokers (max. 10 cigarettes per day) are allowed to participate in this clinical trial. 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 only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.
• As a male no contraception measures are needed.

Note:

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening for this clinical trial (counting from the follow-up visit from the previous study).
• 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 1 period during which you will stay in the research facility in Groningen for 40 days (39 nights), followed by 4 short visits.

The last short visit is the follow-up visit which will take place around 27 days after your departure from the research facility.

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.