Group A1a
- 17 up to and including 20 December
Period(s) of stay (4 days)
- 17 up to and including 20 December
- €1212,-
Compensation
- €1212,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 55 years old
- You weigh more than 50 kg
- Your Body Mass Index (BMI) is between 18 and 32 kg/m2
- Non-smoker
Good to know about this trial
In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body.
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
In this trial it will be investigated how safe the investigational compound is and how well it is tolerated when it is used by healthy participants. Also, it will be investigated how quickly and to what extent the investigational compound is absorbed, transported and eliminated from the body.
The trial consists of three parts: part A, part B and part C. In part A you will receive the new compound once. One group in part A will consist of two periods where you receive the new compound once each period. The effect of food on this new compound will be investigated in this group. In part B you will receive the new compound once daily for 10 days. In part C we investigate whether approved compounds that are already available on the market (rosuvastatin, furosemide, midazolam, flurbiprofen and repaglinide) have an influence on the way the new compound is processed and eliminated by the body. This part will consist of two periods where you will receive the new compound once daily for 10 days in the second period.
Only for part A and B: During the trial your heart rhythm will be monitored for approximately 25 hours at one (part A) or two (part A food effect and part B) different moments. You will be given electrodes (small, plastic patches) on your chest and abdomen that are connected to a portable device. As soon as you are connected, you cannot use electric devices (razor, electric toothbrush, hairdryer) for the duration of the heart monitoring. The use of a phone or laptop is allowed, except for the moments you need to lay down. At certain time-points you will be asked to remain lying down for 15 minutes without moving, talking or sleeping.
WHO CAN PARTICIPATE?
Target group
- 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 and your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2.
- You have not smoked regularly for at least 3 months prior to screening. Occasional smoking (no more than 1 cigarette per day) may be allowed, except you cannot smoke 21 days prior to admission in the research facility.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the compound administration in this clinical trial (counting from the follow-up visit).
- To determine if you are suitable to participate in this trial, you will undergo a medical screening.
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions from 4 weeks prior to the first administration in this trial:
- 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);
- You are not sexually active according to your lifestyle;
- You are only sexually active with a partner of the same sex.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Compensation
- You will receive a gross compensation of € 1646 for participation in one of the groups of part A.
- You will receive a gross compensation of € 2948 for participation in the food effect group in part A
- You will receive a gross compensation of € 3599 for participation in one of the groups of part B.
- You will receive a gross compensation of € 4901 for participation in one of the groups of part C.
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.
HOW LONG DOES THIS RESEARCH TAKE?
Period of stay and research
The trial consists of three parts: part A, part B and part C. You can only participate (in one group of) one part in this trial.
Part A: This part consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 5 to 7 days after your departure from the research facility.
Part A food effect: This group consists of 2 periods during which each period you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 5 to 7 days after your last departure from the research facility.
Part B: This part consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 15 days (14 nights). The follow-up visit will take place 5 to 7 days after your departure from the research facility.
Part C: This part 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). The second period you will stay in the research facility for 15 days (14 nights). The follow-up visit will take place 5 to 7 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.
Frequently asked questions
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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.
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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.
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A trial usually involves 5 to 12 participants. The groups are set up so they best match the requirements of the trial. These requirements are described for each trial. View all current trials.
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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.