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 B3b | |
| 13 Tage Aufenthalt | - 26 Mai up to and including 7 Juni
|
| Anmerkung | - 4 Juli (phone call)
- Follow up takes place at June 11 or 12.
|
| Group B4a | |
| 13 Tage Aufenthalt | - 24 Juni up to and including 6 Juli
|
| Anmerkung | - 2 August (phone call)
- Follow up takes place at July 10 or 11.
|
| Group B4b | |
| 13 Tage Aufenthalt | - 30 Juni up to and including 12 Juli
|
| Anmerkung | - 8 August (phone call)
- Follow up takes place at July 16 or 17.
|
Aufwandsentschädigung
For participation in one of the groups of part B of the trial, you will receive a gross compensation of €3199.
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.
