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Inflammatory diseases

Ort der Studie

Nederland (1)
Groningen

Geschlecht Beides
Alter von 18 bis 55
BMI von 18 bis 30
Berechnen Sie Ihren BMI hier

Inflammatory diseases

Clinical trial of a new compound that is being developed for the treatment of inflammatory diseases

The research physician about this research

This trial consists of three parts: part 1, part 2 and part 3. You can participate in one of the parts.

This trial will investigate how safe the study drug is and how well it is tolerated. It also investigates how quickly and to what extent the study drug is absorbed, transported, and eliminated by the body. In addition, we look at the effect of the study drug on a protein that is important in reactions of the body's immune system.
In each group of part 1, single doses of the study drug or placebo will be investigated at different strengths. One group of part 1 also examines the effect of different capsule strengths. This group will spend several inhouse periods in the research facility.
In part 2 of the trial the study drug will be given once after a high-fat breakfast, once after a low-fat breakfast and once without a breakfast to see if food changes the uptake of the study drug.
In part 3, there is a twice-daily administration over a period of 14 days.
In part 1 and 3, one hour before administration, your heart will be continuously monitored for 24 hours. At certain times you must lie still for 15 minutes without moving, talking or sleeping. You also cannot listen to music, watch TV or use a laptop or phone during this time. As long as you are connected to the device that monitors your heart continuously, you cannot take a shower and you must behave as calmly as possible to prevent that you will sweat.
In part 1 and 3, the effects of the study drug are compared to the effects of a placebo. A placebo is a compound without any active ingredient. It is determined by lot whether you get the study drug or the placebo.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können.

Important information about this study

Both smokers and non-smokers are allowed to participate in this clinical trial
You will only receive the medication once in part 1 and part 2
This trial only includes a stay and a follow-up
The drug is administered in the form of a capsule

Group 3.2b

22 Tage Aufenthalt
4 Jul 2023 bis einschl. 25 Jul 2023

Nachuntersuchung
Nach Vereinbarung zwischen 1 Aug 2023 bis einschl. 3 Aug 2023

€ 4.480

Who can participate?

You are a healthy male or female
You are between 18 and 55 years old .
You weigh at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m².
Both smokers and non-smokers are allowed to participate in this clinical trial. 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 month 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.

As a female you can only participate if you have not been pregnant in the 6 months prior to the screening, have not breastfed in the 3 months prior to the screening, and meet one of the following conditions:

You use contraception (for example the contraceptive pill or 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 female;
You are not sexually active according to your lifestyle.

As a male you can only participate if you meet one of the following conditions:

You use 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 only sexually active with a male;
You are not sexually active according to your lifestyle.

Compensation

You will receive a gross compensation of € 1820 for participation in one of the groups of part 1.
For participation in the group of part 1 that has multiple periods, you will receive a gross compensation of € 4860.
For participation in one of the groups of part 2, you will receive a gross compensation of € 4860.
For participation in one of the groups of part 3, you will receive a gross compensation of € 4480.

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.

Period of stay and research

Part 1 of the trial consists of 1 period during which you will stay in the research facility in Groningen for 8 days (7 nights). The follow-up visit will take place 7 to 9 days after your departure from the research facility.

One group of part 1 consists of 3 periods during which you will stay in the research facility in Groningen for 8 days (7 nights) each period. The follow-up visit will take place 7 to 9 days after your last departure from the research facility.

Part 2 of the trial consists of 3 periods during which you will stay in the research facility in Groningen for 8 days (7 nights) each period. The follow-up visit will take place 7 to 9 days after your last departure from the research facility.

Part 3 of the trial consists of 1 period during which you will stay in the research facility in Groningen for 22 days (21 nights). The follow-up visit will take place 7 to 9 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. The location in Groningen is the Van Swietenlaan 6.

Particulars

This trial consists of three parts: part 1, part 2 and part 3. You can participate in one of the parts.
This trial will investigate how safe the study drug is and how well it is tolerated. It also investigates how quickly and to what extent the study drug is absorbed, transported, and eliminated by the body. In addition, we look at the effect of the study drug on a protein that is important in reactions of the body's immune system.
In each group of part 1, single doses of the study drug or placebo will be investigated at different strengths. One group of part 1 also examines the effect of different capsule strengths. This group will spend several inhouse periods in the research facility.
In part 2 of the trial the study drug will be given once after a high-fat breakfast, once after a low-fat breakfast and once without a breakfast to see if food changes the uptake of the study drug.
In part 3, there is a twice-daily administration over a period of 14 days.
In part 1 and 3, one hour before administration, your heart will be continuously monitored for 24 hours. At certain times you must lie still for 15 minutes without moving, talking or sleeping. You also cannot listen to music, watch TV or use a laptop or phone during this time. As long as you are connected to the device that monitors your heart continuously, you cannot take a shower and you must behave as calmly as possible to prevent that you will sweat.
In part 1 and 3, the effects of the study drug are compared to the effects of a placebo. A placebo is a compound without any active ingredient. It is determined by lot whether you get the study drug or the placebo.

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