Die Studie

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

Who can participate?

  • You are a healthy male or female.
  • You are between 18 and 54 years old. 
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 29.9 kg/m2.
  • Only non-smokers are allowed to participate in this study.

Note:

  • 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.
  • For COVID-19 vaccination the following conditions apply:
    • If you have received / planned to receive an mRNA vaccine (Pfizer or Moderna), then you are allowed to have this vaccination prior to the study, between the study periods and after the conduct of the study.
    • If you have received / planned to receive a vaccine from AstraZeneca or Janssen prior to dosing, then you can participate if you have no symptoms for 2 weeks. Vaccination during study is only allowed at least 2 weeks after the last dosing.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

As a female you are only allowed to participate in this study if you have not used hormonal contraception in the past year, you are not pregnant or breast-feeding and meet one of the following conditions:

  • 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.
  • Females who are breastfeeding or pregnant cannot participate.

As a male you are only allowed to participate if you meet one of the following conditions:

  • 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.

Zeitraum

The study consists of multiple groups. You can only participate in one of the groups.

  • The study consists of 2 periods of 8 days (7 nights) each in our research facility in Groningen. After the last period of stay you will have to return once for your follow-up visit, which will take place 21 to 28 days after your last period of stay. A follow-up telephone call will take place 32 to 39 days after your last period of stay.
  • Before you can leave the research facility on the last day of (each) period, several final health checks will be performed. For some of the health checks the results are not immediately available, therefore there is a possibility that you can only leave the clinic in the afternoon. Also, there is a small chance that you will have to stay longer in the research center based on these results. If this happens, the compensation will be increased in proportion to the number of extra days.

If the dates change you will be notified as soon as possible.

 

Group 1c  
stay  
  • 19 Sep 2022 up to and including 26 Sep 2022
  • 3 Oct 2022 up to and including 10 Oct 2022
 
follow-up  
  • 31 Oct 2022 up to and including 7 Nov 2022
 
note Follow up by phone on appointment on November 11 and 18, 2022

 

Group 1d  
stay  
  • 15 Oct 2022 up to and including 22 Oct 2022
  • 31 Oct 2022 up to and including 7 Nov 2022
 
follow-up  
  • 28 Nov 2022 up to and including 5 Dec 2022
 
note Second follow up by phone on appointment between: December 09 - 16, 2022

Aufwandsentschädigung

  • You will receive a gross compensation of € 3422 for full participation in the 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, irrespective of the method of transportation.