Die Studie

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

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 50 kg
  • Your Body Mass Index (BMI) is:
    • at least 18 and at most 32 kg/m2 for part A, B and C.
    • at least 18 and at most 30 kg/m2 for part D. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (maximum of 5 cigarettes per day). 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 (about 4 and a half weeks) prior to the screening of this clinical trial (counting from the last dosing).
  • 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 female you can only participate if you meet one of the following conditions:

  • You have passed menopause (no periods for at least 12 months);
  • You have been sterilized or due to other reasons are sterile.

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

  • You are using a condom during sexual intercourse;
  • You are not sexually active according to your lifestyle.

Zeitraum

The trial consists of 4 parts: part A, part B, part C and part D. You can only participate in one part of this clinical trial.

Part A consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). The follow-up visit will take place on the day of your departure from the research facility. 21 to 27 days (about 4 weeks) after your departure from the research facility, you will be contacted by phone for some questions.

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

 

Group A5b  
7 Tage Aufenthalt  
  • 7 up to and including 13 Mai
 
Anmerkung  
  • 6 Juni (phone call)
 

Aufwandsentschädigung

For participation in one of the groups of part A of the trial, you will receive a gross compensation of €1668.

 

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.

Zusätzliche Information

  • The trial consists of 4 parts: part A, part B, part C and part D.
    • In part A you receive the compound once.
    • In part B you receive the compound once or twice daily for 10 days (about 1 and a half weeks).
    • In part C you receive the compound twice daily for 14 days (about 2 weeks).
    • In part D you receive the compound twice in combination with an approved medicine.
  • For part A, part B and part D: During the trial your heart rhythm and blood pressure will be continuously monitored during certain periods.
  • For all parts: on some days, during the trial, you have to fast up to 14 hours.