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BO0006-0983-GRQ

Eye disease and liver inflammation

  • M
  • 18 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of an eye disease and liver inflammation

  • From Februar 2026
  • 11 days (Spread over several periods)

€2629,-

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Julian

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 55 years old
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2

Good to know about this trial

  • This is a clinical trial with a radioactive (14C) labeled compound.
  • The follow up appointment will take place during the last period of stay 
  • The study compound has been administered to healthy participants before

 

Wie funktioniert es

Wie funktioniert es?

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Study groups

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The research physician about this research

Additonal information

  • The study compound is a new compound that may potentially be used for the treatment of an eye disease (geographic atrophy) and other inflammatory disorders such as liver inflammation. Geographic atrophy causes the central part of the retina to gradually deteriorate over a larger area. This leads to severe loss of contrast and sharp vision. The study compound works by blocking a compound that causes inflammation in the body.
  • The study compound has been administered to healthy participants before.
  • The study compound will be given once as a drink, after that, the study compound will be given once more administered directly into a blood vessel via an infusion, which will take 15 minutes.
  • This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done 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 radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in 1 month. 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.

So far, the study compound was only given to healthy participants. Study doctors did not report any side effects that they thought were caused by the study compound. There is always the risk of developing side effects which are not currently known.

Prior to the medical screening, you will receive written information about the trial, including information about 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 question 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 male.
  • You are at least 18 and at most 55 years old.
  • Your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m2. 
  • Non-smokers and light smokers or occasional smokers (maximum of 10 cigarettes per day) are allowed to participate in this clinical trial. Smoking is not permitted in the 48 hours prior to arrival at the research center until the end of the study. This amounts to 16 days in total.
     
  • You can only participate if you meet one of the following conditions:
    • You use a condom with your fertile female partner (throughout the study and for a period of at least 90 days after dosing), even if you are sterilized;
    • 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.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the first compound administration in this clinical trial (counting from the last dosing).
  • 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. This condition does not apply to microdose (14C) studies. These
  • Om te bepalen of je geschikt bent voor deelname aan dit onderzoek, zal je medisch worden gekeurd. Afhankelijk van de beschikbaarheid kan dit in Groningen of Utrecht plaatsvinden.

What is the compensation for this research?

Compensation

You will receive a gross compensation of € 2629 for participation in this study.

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net 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 3 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6).

In the first period your stay will be for 7 days (6 nights). During the second and third period you will stay in the research facility for 2 days (1 night). The follow-up visit will take place during the last period.

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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