Group 1
- 14 up to and including 30 May
Period(s) of stay (17 days)
- 14 up to and including 30 May
- 13 June (phone call)
Follow-up
- 13 June (phone call)
- €3838,-
Compensation
- €3838,-
Find out if you qualify for this trial
- You are a healthy male or female
- You are between 18 and 65 years old
- Your Body Mass Index (BMI) is between 18 and 30.5 kg/m2
- Non-smoker
Good to know about this trial
- The study compound has previously been administered to 33 healthy participants.
- Currently, the drug is being used in the treatment of 11 patients.
- The compound is administered in both capsule and tablet forms.
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
The study compound is a new compound that may potentially be used for the treatment of inherited metabolic diseases.In this study we will investigate how quickly and to what extent the study compound is absorbed and eliminated from the body when administered as a capsule that you swallow compared to administration as a tablet that dissolves when placed on your tongue.
The trial consists of two parts: group 1 and group 2. You can participate only in one of the two groups. In group 1 you will receive the study compound three times as a capsule or tablet. In group 2 you will receive the study compound two times as a capsule or tablet with and without breakfast.
Who can participate in this trial?
Target group
- You are at least 18 and at most 65 years old.
- Your body Mass Index (BMI) is at least 18.0 and at most 30.5 kg/m2.
- You do not smoke and you have not used any nicotine-containing products within 2 months prior to the medical screening.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 90 days prior to dosing in the research facility (counting from the last dosing in the previous study).
- 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:
- You are using hormonal contraception (for example the contraceptive pill or intra-uterine device) 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 fertile 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.
WHO CAN PARTICIPATE?
Compensation
- You will receive a gross compensation of €3838 for participation in group 1 of this trial.
- You will receive a gross compensation of €2753 for participation in group 2a or 2b.
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
Trial Period
Group 1:
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 17 days (16 nights). There will be a follow-up phone call 14 to 16 days after your departure from the research facility.
Group 2:
There are two possibilities, group 2a or 2b. The difference between group 2a and 2b is that you will receive the study compound as a capsule or as an orally dispersible tablet (dissolving tablet). Just before the start of group 2 of the study it will be known which group will be conducted.
Group 2a or group 2b
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 12 days (11 nights). There will be a follow-up phone call 14 to 16 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.
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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Your participation in a clinical trial is always voluntary. You can therefore decide to stop at any time. Sometimes you have to stop. For example because of family circumstances or if the doctor decides it is better for your health. If you stop, we will look at what portion of the compensation you are entitled to. It's only fair!
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We pay the compensation for your participation, including travel expenses, within 21 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.