The study compound may potentially be used for the treatment of a rare intestinal disorder, called CIPO (chronic intestinal pseudo obstruction). CIPO is a disorder in the automatic movements of the gastrointestinal tract that causes food or stool to become stuck. This serious disorder can occur at any age. The complaints occur intermittently but are often long lasting, including nausea and vomiting, constipation, a swollen abdomen, and attacks of severe abdominal pain.

In this study we will compare the extent of absorption of the study compound by the body after oral administration (capsule via the mouth) with administration directly into a vein (intravenously). We also investigate how safe the study compound is and how well it is tolerated when it is administered to healthy people.

The study consists of two phases: a test phase followed by the actual study. You can participate in only one of the groups of one of these phases. In the test phase, you will be given a solution of the study compound directly into a vein via a 2-hour infusion. The actual study consists of 2 periods. In period 1, you will be given the study compound as a capsule via the mouth, and in period 2 you will be given it directly into a vein via a 2-hour infusion, or vice versa. The order of these treatments will be determined by chance.

The study compound has been administered to humans before. In addition, it has been extensively tested in the laboratory and on animals.

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• You are a healthy male or female.
• You are at least 18 and no more than 55 years old.
• You weigh at least 50 kg and your Body Mass Index (BMI) is higher than or equal to 18.0 and lower than or equal to 30.0 kg/m². The BMI shows the relationship between body weight in kilograms and height in meters.
• Both non-smokers and light smokers (max. 5 cigarettes per day) are allowed to participate in this clinical trial. Within 48 hours prior to your first admission to our research facility and 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 breastfeeding 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 you can only participate if you meet one of the following conditions:
• Als man kan je alleen deelnemen wanneer je aan één van de volgende voorwaarden voldoet:
  • You are using a condom in combination with an additional contraception method used by your female partner contraception (for example the contraceptive pill or intra-uterine device);
  • You have been sterilized or your female partner is sterilized or has passed the menopause (no periods for at least 12 months);
  • You are only sexually active with a partner of the same sex;
  • You are not sexually active according to your lifestyle.

Let op: 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 visit of the previous trial).

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 test phase of the study consists of 1 period during which you will stay at the research center in Groningen for 3 days (2 nights), followed by 2 telephone follow-up calls.

The actual study consists of 2 periods during which you will stay at the research center in Groningen for 8 days (7 nights) per period. Each period is followed by 1 telephone follow-up 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. The location in Groningen is Van Swietenlaan 6.