Die Studie

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

Study of a new compound that is being developed for the treatment of blood clotting disorders.

Particulars:

  • You are a healthy male or female between 18 and 54 years old.
  • Only non-smokers are allowed to participate in this study.
  • Your weight is between 50 and 100 kg and your Body Mass Index (BMI) is between 18.0 and 29.9 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • You have not participated in any other drug study (counting from the last drug administration) within 1 month preceding the first administration of this study. For specific studies this could be 3 months.
  • As a male you are only allowed to participate in this study if:
    • You use a condom;
    • or you have been vasectomized at least 6 months before the start of the study;
    • or your female partner is postmenopausal (at least 12 months without menstruation) or surgically sterilized (at least 6 months);
    • or you are only sexually active with a male;
    • or you are fully abstinent (not sexually active) in accordance with your lifestyle.
  • As a female you are only allowed to participate in this study if:
  • you do not use hormonal contraception and have not used it in the last year
    • you use a copper intrauterine device;
    • or you are postmenopausal (at least 12 months without menstruation);
    • or you were surgically sterilized at least 6 months before the start of the study, or your partner is sterilized;
    • or you are only sexually active with a female;
    • or you are fully abstinent (not sexually active) in accordance with your lifestyle.
  • Women who are breastfeeding or pregnant cannot participate.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Zeitraum

Group 2a, 2b, 2c or 2d consists of 1 period of 13 days (12 nights) in our research facility in Groningen. After this period of stay you will have to return once for your follow-up visit, which will take place 3 – 5 days after your last stay. 

Group 13 days stay Follow up
Group 2a 16 Sep 2020 up to and including 28 Sep 2020 Follow-up visit by appointment takes place between 01 - 03 October
Group 2b 30 Sep 2020 up to and including 12 Oct 2020 Follow-up visit by appointment takes place between 15 - 17 October

 

Aufwandsentschädigung

You will receive a gross compensation of € 2.003,- for full participation in group 2a, 2b, 2c or 2d. 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, irrespective of the method of transportation.