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VA6173-0009-GRQ

Abnormalities of blood vessels

  • M
  • 18 - 65 years old
  • Healthy

Clinical trial of a new compound that is being developed for the treatment of abnormalities of blood vessels (previous code VREBKM44-0H1Z8)

Very positive experience. You are guided through the process step by step. 

Maurice

Deelnemer 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 30 kg/m2

Good to know about this trial

  • The compound has already been tested in healthy individuals and is being tested in patients with a type of blood vascular malformation in an ongoing study.
  • 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.
  • This study previously had code VREBKM44-0H1Z8D.

 

How does it work

How does it work?

Read more

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

The study compound may potentially be used for the treatment of diseases caused by abnormalities of blood vessels. Vascular malformation is a rare condition that affects the vascular system, which include veins, arteries and lymph vessels. These malformations are a result of the abnormal growth and development of a single type of vessel or a combination of vessels. Instead of normal, smooth networks of vessels, the vessels enlarge or develop an abnormal shape and structure that cause abnormal blood flow. Over the years, malformations can grow larger and become problematic depending on the type of vessel.

Who can participate?

Target group

  • You are a healthy male.
  • You are at least 18 and no more than 65 years old.
  • Your Body Mass Index (BMI) is higher than or equal to 18.0 and lower than or equal to 30.0 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
  • Both non-smokers and light or occasional smokers (max. 5 cigarettes, 1 cigar or 1 pipe per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

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 follow-up visit of the previous trial).
  • 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. If a compound with a negligible radioactivity amount was administered in a previous study, you might be allowed to participate. Please contact 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;
    • 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 € 4690 for full participation in this trial. If you have to return for (one of the) 24-hour visits, you will receive a gross compensation of € 271 per 24-hour visit.

Reiskosten worden vergoed op basis van kilometers (€ 0,21 netto per kilometer) met een minimum van € 13,- en een maximum van € 176,40 (840 kilometer) per retour, ongeacht de wijze van vervoer.

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 for 16 days (15 nights). Depending on the radioactivity levels in your body at the end of the stay, you may have to return to the research facility for a maximum of four 24-hour visits, until radioactivity levels are low enough. The follow-up visit will take place between 7 to 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

Read more about the research

Other 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 2 to 3 months. 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 has already been tested in healthy individuals and is being tested in patients with a type of blood vascular malformation in an ongoing study. In these studies, the following side-effects were observed most often: headache, fatigue, and skin rash. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the study, which also describes the possible side effects. This information will also be discussed with you during the medical screening. You can then ask questions to the screening physician or nurse. The medical screening will only take place after you have given written consent to participate in the study. We want to emphasize that even after giving written consent, participation in any study is voluntary. You can decide at any time not to participate or to stop the medical screening or the study. You do not need to provide a reason for why you no longer wish to participate.

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 bijwerkingen. 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 geneesmiddelenonderzoek, moet je een paar keer per dag iets doen voor het onderzoek, zoals een test of gezondheidscheck. Maar je hebt ook veel tijd voor jezelf! In het onderzoekscentrum vind je van alles om die tijd mee in te vullen. Er zijn bijvoorbeeld computers, Playstations, tv’s met Netflix, maar ook een tafeltennistafel, pooltafel en een dartbord. En natuurlijk is er wifi, dus neem gerust je eigen laptop of tablet mee. Sommige deelnemers gaan voor hun werk of studie aan de slag. Maar je kunt natuurlijk ook een paar dagen lekker ontspannen.

Hoeveel geld je krijgt voor jouw deelname aan een geneesmiddelenonderzoek, wordt bepaald door de duur van het onderzoek. Hoe langer het onderzoek duurt, hoe hoger de vergoeding. Maar er zijn meer factoren die de hoogte van de vergoeding bepalen, zoals speciale medische handelingen.

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