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PRA-RPUBFE61-0D1PX8

Autism

  • M
  • 18 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for autism and Angelman syndrome

Super, never done a study before but ICON did a great job

Maurice

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male
  • You are between 18 and 55 years old
  • You weigh between 50 and 110 kg
  • Your Body Mass Index (BMI) is between 18.5 and 30 kg/m2

Good to know about this trial

  • The study compound has been administered before to healthy humans, those with ASD and those with AS.
  • The study compound will be administered once as a capsule (by the mouth) together with an intravenous infusion (administration directly into a blood vessel).
  • The medical screening will take place in Groningen or Utrecht

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 is being developed for the treatment of autism spectrum disorder (ASD) and Angelman syndrome (AS). People with ASD have challenges with communication, social skills, and behavior that is repetitive or unusual behavior. AS is a rare genetic disorder that has some genetic similarities with ASD. 
  • In this clinical trial, we investigate how the study compound is processed and eliminated by the body and how well it is tolerated when it is used by healthy participants.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

The research physician about this research

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 at most 110 kg and your Body Mass Index (BMI) is at least 18.5 and at most 30 kg/m2 (inclusive). 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). 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 screening of this clinical trial (counting from the follow-up visit). This might be longer for certain trials, please 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. This restriction does not apply for microdose (14C) studies. These studies have a negligible amount of radiation burden, 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.

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 € 3763 for participation in this trial. For an additional 24-hour visit you will receive a gross compensation of € 263 per 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.

Hoe lang duurt het onderzoek?

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 13 days (12 nights). If not enough radioactivity has left your body after 13 days, there will be one more 24-hour visit. The follow-up visit will take place 7 - 10 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. 

Extra 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.

MORE INFORMATION ABOUT A LUMBAR PUNCTURE

Explanation video

Frequently asked questions

Unfortunately, not all side effects of a drug can be predicted. However, doctors can estimate which side effects will occur based on previous research. During the study, the doctors and nurses carefully monitor participants. 

No. The amount of compensation for participating in a trial is based on the length of the trial. The longer the trial lasts and the more times you need to come back in, the higher the compensation. The compensation is provided to reimburse you for your time as a participant. The Medical Research Ethics Committee (MREC) ensures that the compensation is reasonably proportionate to the time you spend as a participant.

You may take part in four studies per year. There must be a period of at least 30 days between each study. A longer waiting time applies for some studies. 

Besides the set moments for the research, you have a lot of time for yourself. The research centers offer wireless internet, TVs with a DVD or Blue-ray player or Netflix, as well as computers and video game consoles in the living room. You can also play darts, pool and table tennis. Some participants really take this time for themselves. They study or read a book. During longer studies, ICON organizes activities and workshops. 

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