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PRA-BIDBFN25-0D1QL2

Depression

  • M
  • 18 - 55 years old
  • Healthy

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

  • From September 2024
  • 11 days

€2711,-

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 55 years old
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2

Good to know about this trial

  • Light smokers can also participate in this study.
  • The medical screening can take place in Groningen or Utrecht

 

How does it work

How does it work?

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Study groups

Register without obligation for the group of your preference

THE RESEARCH PHYSICIAN ABOUT THIS RESEARCH

Additional information

In this study it will be investigated how quickly and to what extent the study compound is absorbed, broken down, transported, and eliminated by the body after an ingestion by mouth of one single solution. The study compound has previously been studied in clinical trials in healthy participants. For this study, the study compound is radioactively labelled. This makes it possible to track the drug in blood, urine and feces. The radiation burden is negligible because the amount of radio labelled compound is very small. During the trial, blood, urine and feces will be collected. It will also be investigated how safe the study compound is and how well it is tolerated when it is used by healthy men.

WHO CAN PARTICIPATE IN THIS TRIAL?

Target group

  • You are a healthy male.
  • You are at least 18 and no more than 55 years old.
  • Your Body Mass Index (BMI) is higher than or equal to 18.5 and lower than or equal to 29.9 kg/m2. The BMI shows the relationship between body weight in kilograms and height in meters.
  • Both non-smokers and smokers (max 10 cigarettes, 3 cigars or 3 pipes per day) are allowed to participate in this clinical trial. However, you are not allowed to smoke during your stay in the research facility.

You can only participate if you meet one of the following conditions during the duration of the trial and up to 90 days after the study compound administration:

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You are using a condom with a pregnant female partner;
  • You are using a condom and you have been sterilized;
  • You are using a condom and 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.

Note:

You cannot participate in the trial if you have participated in another clinical trial in the 60 days prior to the compound administration in this clinical trial (counting from the last administration 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

You will receive a gross compensation of € 2711 for full participation in this trial. Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 174.60 (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 for 7 days (6 nights). Following this you will return for 2 24-hour visits. The follow-up visit will take place on the day of departure of the last 24-hour visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website. The location in Groningen is Van Swietenlaan 6.

Frequently asked questions

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. 

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. 

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