Die Studie

Clinical trial of an existing compound that has undergone a minor change in the production process and that has been developed for the treatment of clotting problems.

Who can participate?

  • You are a healthy male
  • You are between 18 and 55 years old 
  • Your weight is between 50 and 100 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to this clinical trial (counting from the follow-up visit).
  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the first dosing of the study compound and during this trial.
  • 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.

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or postmenopausal;
  • You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle

Zeitraum

  • The trial including the medical screening will be approximately 4 to 6 weeks long.

For each participant the trial consists of a period during which you will stay in the research facility in Groningen for 2 days (1 night), followed by 1 short visit. You will return to our research facility after 10 days and you continue with the study if you meet the desired lab results. If you meet the right criteria, a second period follows of 5 days (4 nights) in the research facility of Groningen. This period will be followed by 3 short visits. The follow-up will take place during the last short visit approximately 2 weeks after the start of the second period. In case you do not meet the desired lab values after 10 days, one follow-up visit will take place within 5-7 days.

PLEASE NOTE: You must be available for all dates to be able to participate in this study.

 

Group A3  
5 days stay 13 Dec 2021 - 17 Dec 2021
short stay 3 Dec 2021 - 4 Dec 2021
short visit  
  • 9 Dec 2021
  • 19 Dec 2021
  • 21 Dec 2021
 
follow-up 28 Dec 2021
Group A4  
5 days stay 16 Dec 2021 - 20 Dec 2021
short stay 6 Dec 2021 - 7 Dec 2021
short visit  
  • 12 Dec 2021
  • 22 Dec 2021
  • 24 Dec 2021
 
follow-up 31 Dec 2021
Group A5  
5 days stay 13 Jan 2022 - 17 Jan 2022
short stay 3 Jan 2022 - 4 Jan 2022
short visit  
  • 9 Jan 2022
  • 19 Jan 2022
  • 21 Jan 2022
 
follow-up 28 Jan 2021
Group A6  
5 days stay 19 Jan 2022 - 23 Jan 2022
short stay 9 Jan 2022 - 10 Jan 2022
short visit  
  • 15 Jan 2022
  • 25 Jan 2022
  • 27 Jan 2022
 
follow-up 3 Feb 2022
Group A7  
5 days stay 25 Jan 2022 - 29 Jan 2022
short stay 15 Jan 2022 - 16 Jan 2022
short visit  
  • 21 Jan 2022
  • 31 Jan 2022
  • 2 Feb 2022
 
follow-up 9 Feb 2022

 

Aufwandsentschädigung

  • You will receive a gross compensation of € 1692 for participation in one of the groups. You will be compensated pro rata in case you do not meet the right values during the study (in proportion to the number of days participated).

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, regardless of the mode of transportation.