Drug study of a new compound that may be used for the treatment of heart failure
Besonderheiten (auf Englisch)
- We are looking for healthy males between 18 and 50 years old and living in The Netherlands or Germany.
- You are Caucasian.
- You do not smoke or are a light smoker. Smoking is not allowed during the clinical stay.
- You weigh at least 60 kg and your Body Mass Index (BMI) is between 18 and 29.9 kg/m2.
- You have not participated in any other drug study within 90 days preceding the first administration of the study compound, calculated from the follow-up screening of the previous study.
- You are only allowed to participate in this study if from the time period from screening until 90 days after last drug intake:
- you use a condom with or without spermicide when you are sexually active. This also applies to vasectomized male participants and,
- your female partner of child-bearing potential must agree to use additional adequate contraception during the study, such as hormonal contraceptive or an intrauterine device. This does not apply to female partners who are post-menopausal (≥1 year without menstruation) or have undergone surgical sterilization.
- To determine if you might be eligible to participate in this study, you will undergo a medical screening in our medical screening center in Groningen.
- If the medical screening shows that you are eligible for participation, you must be willing to return to our medical screening center for a 48-hour holter EKG registration.There you will be connected to the holter device and 48 hours later you must come back to disconnect the holter device again.
- You are also willing to undergo an echocardiograph at the UMCG Hospital in Groningen, if it appears that you are still eligible for participation in the medical screening.
It is important that you understand, speak and read English or Dutch. The drug trial takes place in Groningen in The Netherlands.
Vergütung (auf Englisch)
You will receive a gross compensation of € 2.467,- for full participation, including the 48 hour holter EKG registration and the echocardiograph. Travelling expenses will be reimbursed based on kilometers (€ 0.19 net per kilometer) with a minimum of € 12 and a maximum of € 160 (840 kilometers) per round trip, irrespective of the method of transportation.
Periode und Studie (auf Englisch)
The study consist for each group of 1 period of stay in which you will stay in our research center in Groningen in The Netherlands for 12 days (11 nights).
The follow-up appointment will take place 12 to 15 days after the dosing,
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. These are the dates scheduled for the study; these may be subject to change.
Sonstige Information (auf Englisch)
Conditions for participation
The study will be executed under standardized conditions and you have to stay at the research center. Use of medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including chocolate milk), grapefruit (including juice) and products during the study is not allowed. Also before the study and each period these restrictions apply. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.
12 days stay
8 Aug 2020 up to and including 19 Aug 2020
2 follow-ups by appointment