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PRA-PFZBHD87-0D1TUA

Treatment of cancer

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

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

Register without obligation

Very positive experience. They guide you step by step through the proces. 

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 16 and 32 kg/m2
  • Non-smoker

Good to know about this trial

  • This is a clinical trial with a radioactive (14C) labeled compound.
  • There is no maximum age in this clinical trial.
  • The research compound has been administered to people before. 

 

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

    • 26 September up to and including 9 October
    • 10 up to and including 15 October

    Period(s) of stay
    1 x 14 days, 1 x 6 days

    • 26 September up to and including 9 October
    • 10 up to and including 15 October

    • €5672,-

    Compensation

    • €5672,-

    Within 31 days after stay

    Follow up by phone

    Within 31 days after 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. In this study a microtracer dose will be used which has a negligible radiation burden To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male.
  • You are at least 18 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 16.0 and at most 32.0 kg/m2.
  • Only non-smokers are allowed to participate in this clinical trial (minimum of 3 months non-smoking).

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).
  • 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 timeframe is shorter for microdose studies, please contact us to see if this applies 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 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 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.

THE COMPENSATION FOR THIS TRIAL

Compensation

  • You will receive a gross compensation of € 5672 for participation in this study.
  • 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 2 periods during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for a minimum of 6 days (5 nights) and a maximum of 15 days (14 nights) in the first period and for a period of 6 days (5 nights) in the second period. A follow-up phone call will take place within 31 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.

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 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!

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.

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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