Learn more about this research?
- You do not smoke
- Your body weight is at least 45 kg. Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI reflects the relation between your body weight in kilograms and height in meters.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 2.753, - for full participation in group 2.
You will receive a gross compensation of € 2.701, - for full participation in group 3.
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
Group 2 and 3:
The study consists of 3 periods, for every period you will stay 7 days (6 nights) in our research center in Groningen. Each period will be followed by 2 shorts visits.
Please note: You have to be available for all dates for the group of choice to be able to participate in this study. If the dates do change you will be notified as soon as possible.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 30 days between the follow-up in the previous study and the dosing of this study.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
Information sheet PRA-180571
Type of study
The main purpose of this study is to investigate how quickly and to what extent the study medication is absorbed, distributed, broken down and eliminated from the body. The study medication administered as tablets will be compared to the study medication administered true an infusion.
Furthermore, 2 different types of tablets with the study medication (Formulation A and Formulation B) will be compared. The effect of a meal on the study medication administered as tablets will be investigated as well. Finally, it will also be investigated how safe the study medication is and how well the study medication is tolerated. The study drug is not registered as a drug, but previously administered to humans.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
This study will be performed in 30 healthy male volunteers. The study will consist of 3 groups. Group 1 consist of 6 volunteers and group 2 & 3 consist of 12 volunteers for each group. For group 1, the actual study will consist of 1 period and for groups 2 and 3, the actual study will consist of 3 periods. For each period, you will stay in the research center for 7 days (6 nights). On Day 8 and Day 10 of each period you are expected at the research center for a short visit. The study medication will be given in tablet form. In group 2 the study medication will be given both in tablet form and intravenous (iv; in the vein).
Blood samples will be taken regularly during the study. Urine will also be collected for group 2. Volunteers of groups 2 and 3 will receive a moderate-fat, moderate-calorie breakfast in one period and a high-fat, high-calorie breakfast in another period both of which should be finished completely within 30 minutes.
The moderate-fat, moderate-calorie breakfast consists of:
- 2 slices of (wheat) bread (approximately 70 g)
- halvarine (40% fat) (15 g)
- 2 crackers (30 g)
- 1 portion of cheese or cheese spread
- 1 portion of ham, chicken breast or smoked meat
- 2 portions of jam, or 1 portion of jam and 1 portion of apple spread
- 150-300 mL decaffeinated coffee or tea, or 240 mL water
The high-fat, high-calorie breakfast consists of:
- 2 fried eggs (in 15 g margarine) (approximately 100 g)
- 1 portion of bacon (40 g)
- 1 portion of fried potatoes (115 g)
- 2 slices of (wheat) bread (approximately 70 g) with 15 g margarine
- 1 glass of whole milk (240 mL)
You have to be available for all dates for the group of choice to be able to participate in this study. You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible.
Risks and medical supervision
The study compound may cause side effects. As the study medication is under development, there may be side effects, including allergies, that are not yet known. Previously, a study in healthy volunteers was conducted in which the study medication was administered as single doses with and without food. These doses were all well tolerated. Side effects that were considered to be related to the study medication and that were reported more than once were as follows: headache, diarrhea, nausea, vomiting, increased liver enzymes and dizziness. You may have none or only some of the side effects mentioned above during this study. Many side effects go away after study treatment has been stopped. You should take into account that unknown side effects may occur during the study. However, with the doses to be used in this study no serious side effects are expected.
During the study you will be under strict medical supervision. Prior 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 can only take part in the study if you do not smoke. 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 can take part in the study, you will be medically screened, this screening will take place within four weeks before the start of the study.
- Period of stay
- 3× 7 days
- 5 times
- € 2.701,- until € 2.753,-
Group 3€ 2.701,-
3× 7 days stay
- 16 Jan 2019 up to and including 22 Jan 2019
- 30 Jan 2019 up to and including 5 Feb 2019
- 13 Feb 2019 up to and including 19 Feb 2019
- 24 Jan 2019
- 26 Jan 2019
- 7 Feb 2019
- 9 Feb 2019
- 21 Feb 2019
- 23 Feb 2019
Group 2€ 2.753,-
3× 7 days stay
- 9 Jan 2019 up to and including 15 Jan 2019
- 23 Jan 2019 up to and including 29 Jan 2019
- 6 Feb 2019 up to and including 12 Feb 2019
- 17 Jan 2019
- 19 Jan 2019
- 31 Jan 2019
- 2 Feb 2019
- 14 Feb 2019
- 16 Feb 2019