Die Studie

Clinical trial of a new compound that is being developed for the treatment of worsening heart failure.

  • You are a healthy male or female 
  • You are at least 18 and at most 65 years old.
  • Your Body Mass Index (BMI) is greater or equal to 18.5 and less than or equal to 30.0 kg/m2. 
  • Both non-smokers and smokers (no more than 5 cigarettes or 1 cigar or 1 pipe per day) are allowed to participate in this clinical trial. During your stay in our research facility you are not allowed to smoke.

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 last follow up appointment from a previous clinical trial).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. 

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

  • You are using hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
  • You are using a copper intra-uterine device;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been surgically sterilized  at least 6 months prior to the first compound administration;
  • Your male partner has been sterilized (i.e. vasectomized);
  • You are not sexually active;
  • You are only sexually active with a partner of the same sex.

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 has passed the menopause (no periods for at least 12 months);
  • You are not sexually active;
  • You are only sexually active with a partner of the same sex.

Zeitraum

The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 10 days (9 nights). The follow-up visit will take place between 21 and 23 days after your departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. 

 

Group A5a  
Period of stay  
  • 25 Mai up to and including 3 Juni
 
Follow-up Follow up appointment between 24 jun en 26 jun 2024

 

Group A5b  
Period of stay  
  • 27 Mai up to and including 5 Juni
 
Follow-up Follow up appointment between 26 jun en 28 jun 2024

Aufwandsentschädigung

  • You will receive a gross compensation of € 2514 for participation in this trial. 

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.