PRA-184891

Epilepsy

Study of a new compound that is being developed for the treatment of epilepsy

Particulars

  • You are a healthy male or female between 18 and 60 years old.
  • You do not smoke.  
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2
  • As a male you are only allowed to participate in this study if:
    • you use a condom during intercourse with your female partner during the study and your fertile female partner uses a form of contraception (e.g. the pill).
    • or your female partner is surgically sterilized at least 3 months before the screening visit;
    • or your female partner is postmenopausal for at least 12 months (without menstrual periods).
    • or you are vasectomized at least 3 months before the screening visit;
    • or you are truly abstinent during the study.
  • As a female you are only allowed to participate in this study if:
    • you use a intrauterine device or hormonal contraceptives (e.g. the pill) and your fertile male partner uses a condom
    • or you are truly abstinent during the study;
    • or you are surgically sterilized at least 3 months before the screening visit;
    • or your male partner has been vasectomized at least 3 months before the screening visit;
    • or you are postmenopausal for at least 12 months (without menstrual periods).
  • You have not participated in any other drug study within 3 months preceding the first administration of the study compound.
  • Women who are breastfeeding or pregnant can not participate in this study.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening. Based on the availability this can be done in Utrecht or Groningen.
Calculate BMI

Compensation

You will receive a gross compensation of € 3,698,- for full participation in one of the groups.

Travelling 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 return, irrespective of the method of transportation.

Period of stay and research

For each group the study consists of four periods of stay where you will stay for 7 days (6 nights) in our research facility in Groningen. The follow-up will take place 10 to 14 days after the last dosage in the 4th period.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

Sign up for one of the following study groups

Groep A2

4× 7 days stay

  • 31 jul 2019 up to and including 6 aug 2019
  • 14 aug 2019 up to and including 20 aug 2019
  • 28 aug 2019 up to and including 3 sep 2019
  • 11 sep 2019 up to and including 17 sep 2019
€ 3.698,- Select
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Groep A1

Full

4× 7 days stay

  • 15 jul 2019 up to and including 21 jul 2019
  • 29 jul 2019 up to and including 4 aug 2019
  • 12 aug 2019 up to and including 18 aug 2019
  • 26 aug 2019 up to and including 1 sep 2019
€ 3.698,- Select