Die Studie

Clinical trial of a new compound that is being developed for the treatment of blood coagulation.

  • You are a healthy male or female 
  • You are between 50 and 79 years old 
  • You weigh a minimum of 60 kg and a maximum of 120 kg 
  • You have a Body Mass Index (BMI) of minimum 18.0 and maximum 30.0 kg/m2.
  • You have not smoked in the past 3 months.

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit of the previous study).
  • You cannot participate in the trail if you have participated in the clinical trial CS0372 at QPS, as you are not allowed to have previously received this drug.
  • 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.

Zeitraum

Part 2 of the study consists of a clinic period of 11 days (10 nights).  You will then return to the clinic for another outpatient visit about a week after you leave.

If needed, you might be asked back for 1 extra follow-up visit approximately 1 month after your final visit. You will receive extra compensation for this visit as it is not part of the standard participation.

 

Group 2.4  
period of stay  
  • 7 up to and including 17 Juli
 
visits  
  • 24 Juli
 
follow-up  
  • 7 August
 

Depending on your lab values ??during the follow-up inspection, an additional visit may be necessary. This visit will take place on September 4, 2024. For this last visit you will receive a compensation of €229.

Aufwandsentschädigung

You will receive a gross compensation of € 2.960,- for participation in part 1. 

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 round trip, regardless of the mode of transportation.