Group 1
- 9 up to and including 14 January
Period(s) of stay (6 days)
- 9 up to and including 14 January
- 9 February (phone call)
Follow-up
- 9 February (phone call)
- €2298,-
Compensation
- €2298,-
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 30 kg/m2
- Non-smoker
Good to know about this trial
- The study compound has been administered to 1710 participants before.
- You will receive the compound on day 1 and 2 twice as a tablet via the mouth and only once on day 3.
- In this trial, cerebrospinal fluid will be collected once via an epidural (lumbar puncture). This procedure will be performed safely by an experienced specialist (anesthesiologist).
Study groups
Register without obligation for the group of your preference
THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH
Additional information
In this clinical trial we investigate how safe the study compound is and how well it is tolerated when it is used by healthy participants.
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.
Who can participate?
Target group
- You are a healthy male or female (who has passed the menopause or has been sterilized).
- 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 30.0 kg/m2.
- You do not smoke and you have not used any nicotine-containing products.
Note:
- You cannot participate in the trial if you have participated in another clinical trial in the 30 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. Depending on availability, this can be performed in Groningen or in Utrecht.
- Upon entry in our research facility for the trial there will be an eye examination. This assessment is part of the screening. If unexpected results come out of this, you may not participate in the study.
As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
- You have passed the menopause (no period for at least 12 months);
- You have been sterilized.
As a male you can only participate if you meet one of the following conditions:
- You are using a condom when you are sexually active with a male or female partner;
- You are not sexually active according to your lifestyle.
WHAT IS THE COMPENSATION FOR THIS RESEARCH?
Compensation
- You will receive a gross compensation of €2298 for participation in this trial.
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 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 will take place during your departure from the research facility. Finally, about 28 days after departure a telephone call will be conducted for a final check.
Note: You must be available for all dates to be able to participate in this clinical trial.
Extra information
The study compound is a new compound that may potentially be used for the treatment of autoimmune and chronic inflammatory diseases. Autoimmune diseases are diseases that arise when the immune system (= immune system) attacks cells in the body. Examples include rheumatism (joints) and psoriasis (skin). Chronic inflammatory diseases are those in which inflammation is prolonged or recurrent. Inflammation is the body’s response to an external stimulus or tissue damage. Examples include Crohn’s disease (intestines) and COPD (lungs).
Prior to the study an eye examination will be performed once.
In this trial, cerebrospinal fluid will be collected once via an epidural (lumbar puncture). A fine needle will be inserted at the space between two vertebrae in the lower back. This procedure will be performed safely by an experienced specialist (anesthesiologist).
MORE INFORMATION ABOUT A LUMBAR PUNCTURE
Explanation video
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.