Learn more about this research?
- You do not smoke or do smoke less than 5 cigarettes per day.
- Your weight is between 45 and 110 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- Please note: Females are only allowed to participate in this study if they:
- have been surgically sterilized at least 6 months ago, or
- have been postmenopausal for at least one year and are between 45 and 55 years old.
- To determine if you are eligible to participate in this study, you will undergo a medical screening in our medical screening facility.
You will receive a gross compensation of € 1.421 for full participation in one of the groups 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 each group the study consists of 1 period during which you will stay in our research facility in Groningen (location Martini) for 5 days (4 nights), followed by 6 short visits.
Please note: You have to be available for the entire period 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. If the dates do change you will be notified as soon as possible.e.
Information sheet PRA-175451
Type of study
The purpose of the study is to investigate how safe the study medication is and to what extent the study medication is absorbed, tolerated and eliminated. Also it will be investigated what the effect is on the the body. The study compound is not registered and has not been administered to humans before. It has been previously tested in the laboratory and on animals. This study is not intended to improve your health, but is necessary for the further development of this study medication. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
For each group the study consists of 1 period were you will stay for 5 days (4 nights) in our research facility in Groningen (location Martini), followed by 6 short visits. During the study you will receive the study medication or placebo (compound without an active ingredient) once after your breakfast. The medication will be given as an intravenous infusion for approximately 1 hour. Before the start of the study you will visit the medical screening centre for a medical screening. Blood samples will be taken regularly during the study.
Risks and medical supervision
All drugs have the potential to cause adverse events. Because the study compound will be administered to man for the first time, side effects of the study compound in man have not been reported to date and are unknown. In animal studies, the study medication was generally well tolerated when administered. No adverse findings were noted which would lead to a specific expectation of a side effect in this study. You should be aware that adverse effects may occur during the study. 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 or female with a white or slightly tinted skin between 20 and 55 years old. Your body weight is between 45 and 110 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2 (the BMI reflects the relation between your body weight in kilograms and your height in meters). You are only allowed to participate in the study if you are a light smoker or do not smoke and you are able to abstain from smoking and using nicotine containing products during your stay in the clinical center. As a female volunteer you are only allowed to participate in this study if you are sterilized at least 6 months ago and you are between 20 and 55 years old or if you have been postmenopausal for at least one year and you are between 45 and 55 years old.
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 and during each period there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also mentioned theine) is allowed. Before you are allowed to take part in the study, you will be medically screened. The screening will take place within three weeks before the start of the study.
- Period of stay
- 5 days stay
- 6 times
- € 1.421,-
Group 2A2€ 1.421,-
5 days stay
- 6 Sep 2018 up to and including 10 Sep 2018
- 14 Sep 2018
- 21 Sep 2018
- 28 Sep 2018
- 5 Oct 2018
- 19 Oct 2018
- 1 Nov 2018
Group 2A3€ 1.421,-
5 days stay
- 10 Sep 2018 up to and including 14 Sep 2018
- 18 Sep 2018
- 25 Sep 2018
- 2 Oct 2018
- 9 Oct 2018
- 23 Oct 2018
- 5 Nov 2018