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PRA-NOVBGW10-0D1T8W

Parkinson’s disease

  • M
  • 18 - 55 years old
  • Non-smoker
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of Parkinson’s disease

Register without obligation

Very positive experience. You are very well guided through the proces step by step. 

Maurice

Deelnemer ICON

Register without obligation

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 55 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 29.9 kg/m2
  • Non-smoker

Good to know about this trial

  • The research compound will be administered as a drink
  • The medical screening can take place in Groninge or Utrecht

 

How does it work

How does it work?

  1. 1.

    Registering

    Register for the trail and the group you choose. After your registration, call ICON to discuss the study and make an appointment for your medical examination. This can be done from the next working day after 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 30 days.

Read more

Study groups

Register without obligation for the group of your preference

  • Group 1

    • 14 up to and including 24 August

    Period(s) of stay (11 days)

    • 14 up to and including 24 August

    • 29 August (optional)
    • 5 September (optional)

    Visit(s)

    • 29 August (optional)
    • 5 September (optional)

    • 14 September (phone call)

    Follow-up

    • 14 September (phone call)

    • €3271,- to €3797,-

    Compensation

    • €3271,- to €3797,-

    Depending on the amount of radioactivity that has left your body during the trial period, you may have to return to the research facility for up to 2 times for a 24-hour visit (1 overnight stay).

    Nakeuring

    Depending on the amount of radioactivity that has left your body during the trial period, you may have to return to the research facility for up to 2 times for a 24-hour visit (1 overnight stay).

    Full

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

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 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 55 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.0 and at most 29.9 kg/m2. 
  • You do not smoke and have not used any nicotine-containing products in the last 3 months prior to the screening in this trial.

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 administration). 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 during intercourse (with both a male and a 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 € 3271 for full participation in the trial. In case you have to return for 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?

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 11 days (10 nights). Depending on the amount of radioactivity that has left your body during the trial period, you may have to return to the research facility for up to 2 times for a 24-hour visit (1 overnight stay). The follow-up visit will take place 5 – 10 days after your departure from the research facility. This may be after the trial period or after one of the 24-hour visits. Finally, at most 3 weeks after your follow-up, a short telephonic follow-up will take place.

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

Veelgestelde vragen

Je mag maximaal 4 keer per jaar deelnemen aan een onderzoek. Tussen twee onderzoeken moeten minstens 30 dagen zitten. Voor sommige onderzoeken geldt een langere wachttijd.

Je kunt tijdens het onderzoek last krijgen van milde klachten als hoofdpijn of misselijkheid. Dat kan door het geneesmiddel komen. Maar het kan ook komen doordat je voor het onderzoek bijvoorbeeld nuchter moet blijven. Die bijwerkingen zijn vervelend, maar gelukkig niet gevaarlijk.

Voordat een geneesmiddel op mensen mag worden getest, is het al uitgebreid onderzocht in een laboratorium. Daardoor kunnen we goed voorspellen welke bijwerkingen je eventueel kunt krijgen en kunnen we je daarop voorbereiden. Het komt dus bijna nooit voor dat deelnemers last krijgen van onverwachte bijwerkingen. Een allergische reactie op het middel komt gemiddeld bijvoorbeeld één keer per jaar voor.

Je deelname aan geneesmiddelenonderzoek is altijd vrijwillig. Je mag dus op elk moment besluiten om te stoppen. Soms ben je genoodzaakt om te stoppen. Bijvoorbeeld vanwege familieomstandigheden, of als de arts besluit dat dat voor jouw gezondheid beter is. Als je stopt, bekijken we op welk deel van de vergoeding je recht hebt. Wel zo eerlijk!

Als je meedoet aan een onderzoek waarvoor je langer dan 10 dagen in het onderzoekscentrum verblijft, is het soms mogelijk om (in overleg) bezoek te ontvangen.

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