Learn more about this research?
- You do not smoke.
- Your weight is between 55 kg and 105 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.
- Females are only allowed to participate in this study if:
-> Your uterus, fallopian tubes or ovaries are removed.
-> Or if you are between 45 and 65 years old and you are at least for 1 year post-menopausal.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 986,- for full participation in one of the Groups of Group A1 – A6.
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 groups A1 – A6b the study consists of 1 period were you will stay for 6 days (5 nights) in our research facility in Groningen, followed by 2 short visits to our research center. A follow-up visit will take place 13-17 days after the administration of the study compound, the appointment for this follow-up visit will be made during your stay.
In case it is necessary, we can arrange overnight stays in a B&B for the 2 visits of this study..
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.
Information sheet PRA-177621
Type of study
The study will be performed in 2 parts, Part A and Part B. The purpose of the study is to investigate how safe the study medication is and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect of food will be investigated in group A7 and also the effect of a registered medication for heartburn in combination with the study medication will be investigated.
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 Part A, the study consists for group A1a - A6b of 1 period were you will stay for 6 days (5 nights) in which you will receive the study compound once, after you have fasted for 10 hours. After your clinical stay there will be 2 short visits to our research facility.
The study medication or placebo (medicine without an active ingredient) will be given as a suspension. During the study you will stay in our clinical research center in Groningen (location Martini). Before the start of the study you will visit the medical screening centre. 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. However, the study compound has been studied in animals, only a few abnormalities have been observed. After multiple administrations of high doses mild elevations in some liver enzymes in the blood were observed. After very high doses an increase in the weight of the liver and inflammation of the lining of the stomach were seen.
For group A7 the most observed side effects that occur by using the registered medication for heartburn are: headache, dizziness, constipation and diarrhea.
You should be aware that unknown 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 between 21 and 65 years old. Your body weight is between 55 kg and 105 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 can only take part in the study if you do not smoke.
As a female volunteer you are only allowed to participate if your uterus, fallopian tubes or ovaries are removed and you are between 21 and 65 years old or if you are post-menopausal for at least one year and between 45 and 65 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
- 6 days stay
- 2 times
- € 986,-
Group A6b1€ 986,-
6 days stay
- 2 Oct 2018 up to and including 7 Oct 2018
- 9 Oct 2018
- 13 Oct 2018