Die Studie

Die Studie ist in Englisch. Um Teil zu nehmen, müssen Sie der englischen oder holländischen Sprache mächtig sein.

Study of a new investigational compound that is being developed for the treatment of nervous system conditions such as epilepsy.

Particulars:

  • You must speak and understand English or Dutch to participate and you are living in The Netherlands, Belgium or Germany.
  • For this study we are looking for healthy males and females, between 18 and 54 years old who do not smoke.
  • Your Body Mass Index (BMI) is between 18.5 and 30.0 kg/mand your weight is at least 50kg. The BMI reflects the relationship between your body weight in kilograms and your height in meters.
  • As a female, you are only allowed to participate in this study if:
    • you have been surgically sterilized at least 6 weeks prior to screening, or
    • you have been postmenopausal for at least 12 months.
  • As a male, you are only allowed to participate in this study if:
    • you use a condom until 90 days after the last dose, or
    • you have been surgically sterilized, or
    • you are fully abstinent (not sexually active) during the study as this is your usual lifestyle, or
    • you are only sexually active with a male.
  • You are only allowed to participate in this study if you did not participate in another drug study within 3 months prior to administration of the study compound, counting from the last day in the previous study.
  • You have not  been administered any vaccines within 2 months prior to screening and do not plan to have any vaccines administered until the end of the trial.
  • To determine if you are eligible to participate in this study, you will first undergo a medical screening at our screening center in Groningen or Utrecht.

Zeitraum

The study consists of 1 period of 20 days (19 nights) in which you will stay in our research facility in Groningen, followed by 1 short visit 7 days later. There will be an outpatient follow-up visit for all participants between 14 - 17 days after the final dose. Based on the availability, the short visit and the follow-up visit can take place in Groningen or Utrecht. The study will consist of up to 2 groups of 8 participants each.

Group 20 days stay Short visit Follow up
Group 1 12 Aug 2020 up to and including 31 Aug 2020 7 Sep 2020 Follow-up by appointment between 14 - 17 September 2020
Group 2 19 Aug 2020 up to and including 7 Sep 2020 14 Sep 2020 Follow-up by appointment between 21 - 24 September 2020

Please note: You can only participate in one group of this study. You also have to be available for all dates for the group of choice to be able to participate in this study. The dates of the study will be published on our website www.praclinicaltrials.com. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of €3376 for full participation in group 1 or 2 of this study.

Travel expenses will be reimbursed based on the distance traveled (€0.19 net per kilometer) with a minimum of €12 and a maximum of €160 (840 kilometers) per round trip. The use of public transport is not allowed due to the coronavirus.