In this trial, we investigate how safe the new compound is and how well it is tolerated when it is administered to healthy participants. Furthermore, we investigate how quickly and to what extent the compound is absorbed, transported, and eliminated from the body. We compare the effects of the compound with the effects of a placebo. A placebo is a compound without any active ingredient. The compound has not been used by humans before. It has been extensively tested in the laboratory and on animals.

We also investigate whether your hereditary characteristics have an effect on how your body reacts to the compound. This part of the trial is not mandatory. Furthermore, a blood collection device (Tasso+ device) will be tested in various groups during the trial. The blood is taken trough something similar to scrape or graze and only a minimal amount of blood will be taken. This new device is used to check whether the new compound can be measured in blood collected with this device as reliably as by puncturing a vein.

Approximately 106 healthy male and female participants are planned to take part in this trial. The trial consists of 4 parts: part A, part B, part C and part D. In part A you receive the compound once, in part B you receive the compound once or twice daily for 10 days (about 1 and a half weeks), in part C you receive the compound twice daily for 14 days (about 2 weeks) and in part D you receive the compound twice in combination with an approved medicine.

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.

Part A consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up visit will take place on the day of your departure from the research facility. 21 to 27 days after your departure from the research facility, you will be contacted by phone for some questions. You will receive the study compound or placebo once as a capsule for swallowing, after you have fasted for 10 hours. After you receive the compound or placebo, you will fast for 4 hours. All medication will be given with 240 mL of water. In addition, one time during the study, your heart rhythm and blood pressure is monitored continuously over 48 hours. At certain time-points you will be asked to remain lying down on your back for 15 minutes without moving, talking or sleeping. You may also not listen to music, watch television or use a laptop or phone. During these 15 minutes we measure your resting heart activity. If you are connected to the device, you cannot take a shower and you have to behave as relaxed as possible to prevent sweating. In addition, a blood collection device is tested twice during the study in groups A3, A4 and A5.

Part B consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days after the follow-up visit, you will be contacted by phone for some questions. You will receive the study compound or placebo as a capsule for swallowing once or twice daily for 10 days. On day 1 and day 10 

you will receive the study compound or placebo after you have fasted for 10 hours. After you receive the compound or placebo, you need to fast for 4 hours on day 1 and day 10. On all other dosing dates, you need to fast 2 hours before and 1 hour after you receive the compound or placebo. All medication will be given with 240 mL of water. In addition, two times during the study, your heart rhythm and blood pressure is monitored continuously. The first time over 48 hours, the second time over 24 hours. At certain time-points you will be asked to remain lying down on your back for 15 minutes without moving, talking or sleeping. You may also not listen to music, watch television or use a laptop or phone. During these 15 minutes we measure your resting heart activity. If you are connected to the device, you cannot take a shower and you have to behave as relaxed as possible to prevent sweating.

Part C consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights). The follow-up visit will take place 4 to 5 days after your departure from the research facility. 20 to 26 days after the follow-up visit, you will be contacted by phone for some questions. You will receive the study compound or placebo as a capsule for swallowing twice daily for 14 days, after you have fasted for 2 hours. After you receive the compound or placebo, you will fast for 1 hour. All medication will be given with 240 mL of water. In addition, multiple times during the study, your heart rhythm and blood pressure is monitored continuously. At certain time-points you will be asked to remain lying down on your back for 5 minutes without moving, talking or sleeping. You may also not listen to music, watch television or use a laptop or phone. During these 5 minutes, we measure your resting heart activity. If you are connected to the device, you cannot take a shower, and you have to behave as relaxed as possible to prevent sweating

Part D consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 20 days (19 nights). The follow-up visit will take place 3 to 4 days after your departure from the research facility. 21 to 27 days after the follow-up visit, you will be contacted by phone for some questions. The study compound will be given on day 1 and day 10, the approved medicine will be given from day 6 to day 18. You will receive both compounds as a capsule for swallowing once daily, after you have fasted for 3 hours. After you receive the compound and the approved medicine, you will fast for 4 hours. All medication will be given with 240 mL of water. In addition, one time during the study, your heart rhythm and blood pressure is monitored continuously over 24 hours. At certain time-points you will be asked to remain lying down on your back for 15 minutes without moving, talking or sleeping. You may also not listen to music, watch television or use a laptop or phone. During these 15 minutes we measure your resting heart activity. If you are connected to the device you cannot take a shower and you have to behave as relaxed as possible to prevent sweating. In addition, a blood collection device is tested twice during the study in groups D1 and D2.

During the trial, blood will regularly be drawn and urine will be collected. Prior to screening, 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 confirmed whether you can participate.

Consumption of medication, alcohol, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including juice) 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 will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.

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. The compound has been studied extensively in the laboratory and in animals. In animal experiments the following potential risks in people may be expected: hypotension, increased heart rate, irregular heart rate and muscle pain or muscle injury. 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.

• You are a healthy male or female.
• You are at least 18 and at most 55 years old.
• Your weight is at least 50 kg for all parts, and your Body Mass Index (BMI) is at least 18 and at most 32 kg/m2 for part A, B and C. Your Body Mass Index (BMI) is at least 18 and at most 30 kg/m2 for part D. 
• Both non-smokers and light smokers 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.

• 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 last dosing).
  • 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 are not pregnant and not breast feeding and meet one of the following conditions:
• You have passed menopause (no periods for at least 12 months);
• You have been sterilized or due to other reasons are sterile.
• As a male you can only participate if you meet one of the following conditions:
  • You are using a condom during sexual intercourse;
  • You are not sexually active according to your lifestyle.

For participation in one of the groups of part A of the trial, you will receive a gross compensation of €1668. For participation in one of the groups of part B of the trial, you will receive a gross compensation of €3199.For participation in one of the groups of part C of the trial, you will receive a gross compensation of €4067. For participation in one of the groups of part D of the trial, you will receive a gross compensation of €4718. Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

Besides the set moments for the research, you have a lot of time for yourself. The research centers offer wireless internet, TVs with a DVD or Blue-ray player or Netflix, as well as computers and video game consoles in the living room. You can also play darts, pool and table tennis. Some participants really take this time for themselves. They study or read a book. During longer studies, ICON organizes activities and workshops. 

You may take part in four studies per year. There must be a period of at least 30 days between each study. A longer waiting time applies for some studies. 

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.

ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.