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PRA-TEA22622-22622X

Neurologische Erkrankung Multisystematrophie

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

Arzneimittelstudie mit einem Prüfpräparat, das zur Behandlung einer neurologischen Erkrankung (Multisystematrophie) entwickelt wurde.

Everything was arranged well and professionally

Noah

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 65 years old
  • Your Body Mass Index (BMI) is between 18 and 32 kg/m2
  • Non-smoker

Good to know about this trial

  •  It is studied how quickly and to what extent the compound is absorbed, converted and excreted by the body.
  • The drug is given as capsules by mouth
  • Your participation lasts 23 days

 

Wie funktioniert es

Wie funktioniert es?

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Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

  • The investigational compound may potentially be used as a therapy for the neurological disease, multiple system atrophy (MSA). MSA is characterized by involuntary muscle movements, slow movement, inflexible muscles, disturbed balance and nervous system problems.
  • This is a clinical trial with a radioactive (14C) labeled investigational 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 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.
  • The compound will be administered as capsules via the mouth, once a day for 15 days.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target groep

  • You are a healthy male.
  • You are at least 18 and at most 65 years old.
  • Your Body Mass Index (BMI) is at least 18.0 and at most 32.0 kg/m2. 
  • You do not smoke and you do not use 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 the admission in the research facility (counting from the follow-up visit). This may be longer for certain trials. Contact us for more information.
  • 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. An exception to this are trials with a very low dose of radioactivity, which had a negligible radiation burden. Please reach out to us for more information.
  • 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 in combination with an additional contraception method used by your female partner (such as the pill or an IUD);
    • You have been sterilized or 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH

Compensation

You will receive a gross compensation of € 6393 for participation in the trial. In case you have to return for one or more 24-hour visits, you will receive a gross compensation of € 263 per 24-hour visit.

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

Trail Period

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 23 days (22 nights). Depending on the amount of radioactivity that has left your body after 23 days, you may have to return for at most two 24-hour visits (1 night). The follow-up visit will take place 7 – 9 days after your last departure from the research facility.

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

Trials with radioactive-labeled medication

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.

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. 

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.

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!

We pay the compensation for your participation, including travel expenses, within 30 days of the follow-up screening of the trial. If you have questions about the payment, please contact us.

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