Study of a new compound that is being developed for the treatment of chronic heart failure
- You must speak and understand English or Dutch to participate.
- For this study we are looking for healthy males and females aged between 18 and 55 years old.
- Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- For this study smoking is allowed up to a maximum of 5 cigarettes a day.
- Women are only allowed to participate in this study if they have been postmenopausal for at least one year / have been surgically sterilized.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 1.775,- for participation in one of the groups of part A of this study.
You will receive a gross compensation of € 1.802,- for participation in group A7 of this study.
You will receive a gross compensation of € 2.022,- for participation in one of the groups of part B 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 Part A the study consists of 1 period during which you will stay in our research facility in Groningen for 16 days (15 nights).
For Part B the study consists of 5 periods. During the first four periods, you will stay for 4 days (3 nights) and during the last period you will stay 2 days (1 night). During all periods you will stay in our research facility in Groningen.
The follow-up visit will take place for Part A between day 27 and day 35 (after dosing) and for Part B and C between day 48 and day 55 (after dosing).
You have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 60 days to dosing.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
Type of study
Soon a research study will start at PRA with a new study drug that may eventually be used for the treatment of chronic heart failure. The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics [PK]). The study drug 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
The actual study will consist of two parts: part A and part B.
Part A will consist of 1 period during which you will stay in the clinical research center in Groningen for 16 days (15 nights).
Part B will consist of 5 periods. During the first four periods, you will stay for 4 days (3 nights) and during the last period you will stay 2 days (1 night). During all periods you will stay in our research facility in Groningen.
In part A, you will receive the study drug and / or placebo once in the form of a subcutaneous injection in the belly. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.
In part B, you will receive the study drug and / or placebo once every period, with the exception of the last period, in the form of a subcutaneous injection in the belly. Blood samples will be taken regularly during the study.
Risks and medical supervision
The compound will bind to a protein receptor which will then be activated. This will cause for an increase in heart rate and cardiac output (the volume of blood being pumped by the heart) and a decrease of blood pressure. Therefore, this compound may be used as a treatment of chronic heart failure. 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 / female between 18 and 55 years old. You can only take part in the study if you do not smoke or if you do not smoke more than 5 cigarettes a day. Women must be surgically sterile or post-menopausal.
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 is not allowed. Also, before the study there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine is allowed.
Before you are allowed to take part in the study, you will be medically screened; this screening will take place within four weeks before the start of the study.
16 days stay
- 9 Dec 2018 up to and including 24 Dec 2018
16 days stay
- 21 Jan 2019 up to and including 5 Feb 2019