Learn more about this research?
- You are a non-smoker
- Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and heigth in meters.
- A semen sample will be collected at two occasions during the study. Therefore, you can only participate in this study if you have not been sterilized.
- You must understand English or Dutch to participate.
- To determine if you are eligible for participation in this study, you will undergo a medical screening.
You will receive a gross compensation of €1.197,- for participation in Group B5 of this study.
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 return, regardless of the mode of transportation.
Period of stay and research
For Group B5 the study consists of 1 period, during which you will stay in our research facility in Groningen in The Netherlands for 10 days (9 nights). The follow-up visit will be conducted 4 – 8 days after your departure from the research facility.
Please refer to our website www.pra-arzneimittelforschung.de for more information about researches and a complete overview of the scheduled study dates.
Please note that these are the currently planned dates and that these may be subject to change.
Information sheet PRA-172081
Type of study
The purpose of this study is to investigate how safe the new compound is when it is administered to healthy volunteers. It will also be investigated how quickly and to what extent it is absorbed and eliminated from the body and to what extent it is excreted in semen. The new compound is not registered as a drug and has not been given to humans before.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
During the study you will stay in the clinical research center in Groningen (Martini site) for 10 days (9 nights). On Day 1 to Day 5 the new compound will be given as oral capsules.
Blood samples will be taken regularly during the study and you will be asked to collect a semen sample by masturbation on 2 occasions during the study.
Risks and medical supervision
The new compound may eventually be used for the treatment of heart failure. Heart failure is characterized by the inability of the heart to deliver a sufficient supply of blood and oxygen to the organs in the body. Signs and symptoms may include shortness of breath, tiredness, a limited ability to exercise, and leg swelling. The new compound is able to bind a protein that is expressed in the human heart. Binding of the new compound to the protein exerts a series of signaling events that may result in enhancement of contractility of cardiac cells and mild dilatation of the blood vessels. In heart failure patients, evidence suggests that short-term intravenous infusion of a compound similar to the new compound results in improvement of cardiac output.
The new compound may cause side effects, but since it will be administered to humans for the first time in this study, side effects in humans have not been reported to date. The new compound has been studied in animals and there were no findings related to that. Based on the mechanism of action, side effects may occur that are observed with a similar compound that has been infused in approximately 58 people at doses that are similar (or higher) than those to be used in this study. No significant bad reactions were reported. The similar compound causes blood vessels to open which results in lower blood pressure and faster heart rate. Low blood pressure may cause dizziness, fainting, sweating, nervousness, nausea and chest or abdominal pain. Increased heart rate may cause a sensation of pounding in the chest which may cause feelings of anxiety or nervousness.
You will be under strict medical supervision during the study. Before the study and at the end of the study you will undergo an extensive medical screening.
Conditions for participation
You are a healthy male between 18 and 55 years old. You may only take part in the study if you do not smoke and if you have not been sterilized. The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products during the study are not allowed. Also before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine are allowed.
Before you are allowed to take part in this study, you will be medically screened; this screening will take place within 4 weeks before the start of the study.
- Period of stay
- 10 days stay
- 0 times
- € 1.197,-
Group B-5a€ 1.197,-
10 days stay
- 25 Oct 2018 up to and including 3 Nov 2018
Group B-5a1€ 1.197,-
10 days stay
- 15 Nov 2018 up to and including 24 Nov 2018
Group B-5b€ 1.197,-
10 days stay
- 2 Dec 2018 up to and including 11 Dec 2018