For participation in one of the groups you will receive a gross compensation of € 6519,-. Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

• You are a healthy male or female (postmenopausal).
• You are at least 18 and at most 55 years old.
• Your weight is at least 55 kg and at most 100 kg and your Body Mass Index (BMI) is at least 18.0 and at most 30.0 kg/m2. 
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximal 5 cigarettes per day). During your stay in our research facility and 24 hours before every admission you are not allowed to smoke.

Note:

• 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). For some study compounds this can be 90 days. This will be discussed during your telephone screening.
• 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.
• As a female you can only participate if you meet the following conditions:
  • You have passed menopause (no periods for at least 12 months).
• As a male you can only participate if you meet one of the following conditions:
  • You use a condom with 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.

All potential medicines can cause side effects. As the compound will be administered to humans for the first time in this trial, side effects in humans are not known yet.

Based on the way study compound works, the following side effects may occur: increased bile acids in blood, this can, for example, lead to itching and increased liver enzymes.

These effects are dose-dependent and there is little chance that they occur with the doses selected for this study. Furthermore, these side effects are transient and, except for stomach or intestinal irritation and flu-like symptoms, you will probably not notice these. In addition, if occurring, these effects probably do not have clinical implications.

You should take into account that (serious) side effects may occur that are still unknown. In addition to unknown side effects, there is a (small) chance that an allergic reaction will occur. This can be caused by the study compound or other ingredients that are used to prepare the formulation. During the study, you will be under strict medical supervision. The doctors and investigators of ICON are always well-informed about the compound being studied. With this knowledge they can estimate the effects and side effects reasonably well.

To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial.

The trial consists of 5 periods during which you will stay in the 1^st period in the research facility in Groningen (location van Swietenlaan 6) for 5 days (4 nights), followed by 2 short visits. From the 2^nd period to the 4^th period you will stay  in the research facility for 3 days (2 nights)  each time. During the 5^th period you will stay in the research facility for 4 days (3 nights), followed by 6 short visits. The follow-up visit will take place during the last short visit. The study compound will be given four times by injection.

During the trial, blood will regularly be drawn and urine will be collected. Prior to screening, (each) admission, and the follow-up, you have to stay fasted for 4 hours. You can only drink water prior to your visit. This means that we will ask you to fast prior to any participation in the trial. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.

For 5 days in the trial you will receive a standardized breakfast (this means that all men eat the same and all women eat the same). The entire breakfast must be finished within 20 minutes. All other meals are also standardized on these 5 days. On other days, you will have a normal breakfast. On some days, you will fast up to 4 hours after breakfast until lunch.  

Consumption of medication, alcohol, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including juice), poppy seeds and tobacco/nicotine-containing products are not allowed during the trial. Also, before the start of the trial and when you are not staying in the research facility, there may be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.

If you are participating in a trial for which you have to stay at the research center for longer than ten days, it is sometimes possible to have visitors (in consultation).

During the trial, you may suffer from mild symptoms like headache or nausea. That may be caused by the medication. It might also be caused by needing to fast for the trial, for example. Those side effects are no fun, but fortunately are not dangerous.

Before a medication is tested on people, it has already been studied extensively in a lab. This enables us to predict well which side effects you might get and we can prepare you for them. It almost never happens that participants suffer from unexpected side effects. For example, an allergic reaction to the medication occurs on average once a year.

The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.

You can participate in a trial a maximum of four times a year. There must be at least 30 days between two trials. Some trials have a longer waiting period.