Herzversagen

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 22 and at most 55 years old.
• Your Body Mass Index (BMI) is at least 18.5 and at most 30.0 kg/m². 
• Both non-smokers and very light smokers (maximum of 1 cigarette per day) are allowed to participate in this clinical trial. During your stay in our research facility, you are not allowed to smoke.
• a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:
  • You have passed the menopause (no periods for at least 12 months).
• As a male you can only participate if you meet one of the following conditions:
  • There are no contraceptive requirements for males.

Note: You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening in this clinical trial (counting from the last dosing). For some study compounds this can be 90 days. This will be discussed during your telephone screening.

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

Group 1 and 2
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). After this period there will be 3 short visits. The follow-up will take place during the last short visit. If the results of Group 1 show that more short visits are needed than planned, then Group 2 may have 8 short visits instead of 3 short visits. You will be informed about this at the start of the study.

Group 3
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). After this period there will be 5 short visits. The follow-up will take place during the last short visit. If the results of Group 1 and 2 show that more short visits are needed than planned, then Group 3 may have 8 short visits instead of 5 short visits. You will be informed about this at the start of the study.

Group 4, 5 and 6
The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 7 days (6 nights). After this period there will be 8 short visits. The follow-up will take place during the last short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

Aufwandsentschädigung

You will receive a gross compensation of €2321 for participation in group 1. You will receive a gross compensation of €2387 for participation in group 2. For group 2 you will receive a gross compensation of €3683 if there are 8 short visits needed. You will receive a gross compensation of €2859 for participation in group 3.  For group 3 you will receive a gross compensation of €3683 if there are 8 short visits needed. You will receive a gross compensation of €3683 for participation in group 4, 5 or 6. Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (840 kilometers) per round trip, regardless of the mode of transportation.

Zusätzliche Information

• The study compound is a new compound that may be used for the future treatment of heart failure. Heart failure is when the heart does not pump blood as well as it should. This can result in disease symptoms such as shortness of breath and excess fluid in the legs.
• The study compound has not been administered to humans before, it has been extensively tested in the laboratory and on animals.
• You will receive the study compound as an injection under the skin of the stomach. The total number of injections range from 1 to 6 depending on the group you are assigned to.
• During the study, your heart will be monitored almost constantly for 3 days (telemetry). Stickers (electrodes) will be placed on your chest for this and attached to a device. At various times you will have to lie still for 15 minutes without moving, talking and sleeping, also you will not be able to listen to music, watch TV or use a laptop or phone. Outside of these moments, you can listen to music, watch TV or use a laptop or phone. You can shower daily, then you will be disconnected from the device.