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OR4413-0007-GRQ

Brain disorders

  • M
  • 18 - 64 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of brain disorders

  • From July 2026
  • 16 days

€4811,- to €5367,-

Very comfortable experience:
Friendly people and a relaxed research

Anthony

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 64 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 19 and 25 kg/m2

Good to know about this trial

  • The compound has already been tested in healthy individuals.
  • In this phase we study how your body absorbs, processes and eliminates a medicine.
  • To investigate this, the medicine is labeled with a very small amount of radioactivity. Read more about this type of research here.

 

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

  • The study compound may potentially be used for the treatment of brain disorders. By blocking a certain protein in the brain, the study compound may help reduce harmful brain inflammation. This blockage can also improve the information transfer between brain cells. The study compound will be administered once by mouth on the day after admission in the research center. A small amount of alcohol is used in the composition of the study compound.
  • This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted by the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. The compound has a negligible radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in 2-3 months. This background radiation is released from space, soil, air, water, food and construction materials. To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.

Tested more frequently:

The compound has already been tested in healthy individuals. The compound has been given to 474 participants in 10 previous trials. In these trials the compound was generally safe and well tolerated, the following side-effects were observed: headache and temporary reduction in the number of platelets (blood cells that help with clotting). You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

Who can participate?

Target group

  • You are a healthy man.
  • You are at least 18 and at most 64 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 19.0 and at most 25.0 kg/m2
  • Both non-smokers and light smokers (maximum of 5 cigarettes per day) are allowed to participate in this clinical trial. During your stay in our research facility, you are not allowed to smoke.
  • 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 menopause (no periods for at least 12 months);
    • You are only sexually active with a partner of the same sex;
    • You are not sexually active according to your lifestyle.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the last compound administration). For certain previous trials this period can be 90 days. Please contact us to see if this applies to you.
  • You can only participate in this trial if you have not participated in another trial with a radioactive (14C) labeled compound in the past 12 months. For trials with a very low radiation dose (so-called 14C microdose studies) this timeframe is 30 days, please contact us to see if this is applicable for you.
  • 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.

What is the compensation for this research?

Compensation

You will receive a gross compensation of € 4.811,- for participation in this clinical trial. For each 24-hour visit that is needed you will receive an additional compensation of € 278,-.

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (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 16 days (15 nights). Depending on the levels of radioactivity in your body at the end of your stay, you may have to return to the research facility for a maximum of two 24-hour visits.
If you don’t have to return for a 24-hour visit a follow-up visit will take place within 7 days after your departure from the research facility. Otherwise, this will take place within 7 days after your last 24-hour visit at the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial.

During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.

We are not studying whether there are side effects. Therefore it is not necessary to administer a high dose, reducing the chance of side effects.

During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.

During a clinical trial with radioactive-labeled medication, you are exposed to less than 1 mSv. That is less than the radiation you encounter in daily life. Because we want to make sure that we safely perform 14C trials, the study doctor who conducts these trials is also a radiation expert.

Our doctors, investigators and nurses will keep a close eye on you. If they notice something about your health, they will raise the alarm right away. Additionally, every room has an emergency button and as a participant you are given a personal alarm. If you are not feeling well, then the trial stops right away.

Clinical trials with drugs that are radioactively labeled is mandatory before a new medicine can be registered, and is therefore generally accepted. Radioactively labeling or marking a drug is done to be able to study how quickly and to what extent the drug to be studied is absorbed, converted and excreted in the body. 

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