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PRA-SAVBGA45-0D1RLD

Inflammatory diseases

  • M
  • 18 - 65 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of inflammatory diseases like rheumatoid arthritis and psoriasis

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Every time a very pleasant and educational experience

Milan

Participant ICON

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Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 65 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

  • In this study we will investigate how quickly and to what extent the study compound is absorbed, transported and eliminated from the body.
  • We do this by marking the medicine with a small amount of radioactivity (14C).
  • Read more about this type of study.
  • The study compound has been administered to 162 participants before in 6 studies.

Download the complete reseach overview of part A.

Download the complete reseach overview of part B.

How does it work

How does it work?

  1. 1.

    Registering

    Find a trial that suits you and for which you match the target group, and sign up. We will call you to discuss your registration.

  2. 2.

    Medical screening

    If you meet the requirements of the trial, then a medical screening takes place at our screening center in Groningen or Utrecht.

  3. 3.

    The trial

    The clinical trial is conducted at ICON's research center in Groningen. There you will eat, sleep and stay during the trial.

  4. 4.

    Follow-up & Compensation

    A follow-up screening always takes place after the trial. You will receive the compensation for your participation, within 21 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group A2

    • 28 March up to and including 9 April (Possible extension up to and including 16 April)

    Period(s) of stay (20 days)

    • 28 March up to and including 9 April (Possible extension up to and including 16 April)

    • €5604,- to €6393,-

    Compensation

    • €5604,- to €6393,-

    April 23 - 24

    April 30 – May 1

    May 14 – 15

    Follow-up by appointment between 3 - 7 days after last departure or on May 15 when all visits are necessary.

    Possible 24 hour visits

    April 23 - 24

    April 30 – May 1

    May 14 – 15

    Follow-up by appointment between 3 - 7 days after last departure or on May 15 when all visits are necessary.

    Full

  • Group B2

    • 4 up to and including 16 April

    Period(s) of stay (13 days)

    • 4 up to and including 16 April

    • €3763,-

    Compensation

    • €3763,-

    On appointment between April 19 and 23

    Follow-up

    On appointment between April 19 and 23

    Full

  • Groep B1

    • 30 April up to and including 12 May

    Period(s) of stay (13 days)

    • 30 April up to and including 12 May

    • €3763,-

    Compensation

    • €3763,-

    Between 15 - 19th of May 2024

    Follow up

    Between 15 - 19th of May 2024

    Full

The research physician about this research

Additional information

  • The study compound is a new compound that may potentially be used for the treatment of inflammatory diseases like rheumatoid arthritis and psoriasis. In rheumatoid arthritis the body’s immune system is dysregulated, causing chronic inflammation in the joints.
  • In this study we will investigate how quickly and to what extent the study compound is absorbed, transported and eliminated from the body.
  • The study compound has been administered to 162 participants before in 6 studies.
  • The trial consists of two groups: group A and group B. You can participate only in one of the two groups. In group A you will receive the study compound once as an oral drink. In group B you will receive the study compound once as a tablet and 3 hours later you receive the study compound as 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 be able to study how quickly and to what extent the compound is absorbed, converted and excreted through the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. In both groups the study 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.

Who can participate?

Target group

  • You are a healthy male.
  • You are at least 18 and at most 65 years old.
  • Your weight is at least 50 kg and at most 110 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 within 3 months prior to the medical screening.

Note:

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to screening in the research facility (counting from the last dosing in the previous study).
  • 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 for microdose (14C) studies. Microdose studies have a negligible amount of radiation burden (lower than 0.1 mSv), please contact us for more information and 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.

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 using a condom and your fertile female partner is using an additional contraception method (like the pill or an intra-uterine device);
  • You are not sexually active according to your lifestyle.

What is the compensation for this research?

Compensation

  • You will receive a gross compensation of €5604 for participation in group A of this trial.
    • If there are one or more additional 24-hour visits needed, you will receive a gross compensation of €263 for each 24-hour visit.
  • You will receive a gross compensation of €3763 for participation in group B of 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

Group A:

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for at least 13 days (12 nights) and at most 20 days (19 nights). If you have not excreted sufficient radioactivity after 20 days, one to three 24-hour visits will follow. The follow-up will take place 3 to 7 days after your departure from the research facility or during the last 24-hour visit.

Group B:

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up will take place 3 to 7 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. 

Frequently asked questions

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.

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.

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!

The amount of money you receive for your participation in a clinical trial is determined by the duration of the trial. The longer the trial takes, the higher the compensation. But there are also other factors that determine the amount of the compensation awarded, such as special medical procedures.

ICON often conducts trials with medication that is radioactive-labeled. We do that to be able to study how and how quickly the drug is absorbed, processed and eliminated by the body. In a trial with radioactive-labeled medication, you have less of a chance of side effects than in other trials. This is because a much lower dose is administered in these trials. Read more about trials with radioactive-labeled medication.

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