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- Your weight is at least 60 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- As a male you are only allowed to participate in this study if you meet one of the following:
- are vasectomized at least 6 months before the start of the study;
- use a condom and your female partner an intrauterine device;
- use a condom and your female partner an additional hormonal contraceptive (e.g. the pill);
- are true abstinent during the study.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 670,- for full participation in one of the groups of group A1 – A6.
You will receive a gross compensation of € 2050,- for full participation in one of the groups of group B1 – B6.
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, irrespective of the method of transportation.
Period of stay and research
For group A1 – A6 the study consists of 1 period were you will stay for 5 days (4 nights) in our research facility in Groningen (location UMCG). For group A7 and A8 you will stay in the research facility in Groningen (location Martini). A follow-up visit will take place 7 – 14 days after your discharge from our research facility, the appointment for this follow-up visit will be made during your stay.
For group B1 – B6 the study consists of 1 period were you will stay for 18 days (17 nights) in our research facility in Groningen (location Martini except group B1 location UMCG). A follow-up visit will take place 7 - 14 days after after your discharge from our research facility, the appointment for this follow-up visit will be made during your stay.
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-170021
Type of study
Soon a research study will start at PRA with a new drug that may eventually be used for the treatment of liver diseases.
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 in 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 group A1 – A6 the study consists of 1 period of 5 days (4 nights) in which you will receive the study compound once, after you have fasted for 10 hours. During the study you will stay in our clinical research center in Groningen (location UMCG).
For part B, groups B1 - 6, the study will consist of 1 period of 18 days (17 nights) in which you will receive the study compound once per day for 14 consecutive days, after you have fasted for 10 hours. During the study you will stay in our clinical research center in Groningen (location Martini, except group B1 location UMCG).
The medication will be given as oral tablets with tap water. 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. The study compound has been studied in monkeys and rats, the study compound was well tolerated and a few side effects were seen. There were no safety concerns and in particular no effects on cardiac, pulmonary and neurologic function.
There is limited information on other similar study compounds that are under development: it is known that up to now they have generally shown to be safe. However, the occurrence of pruritus (itchy skin) has been reported in several similar study compounds, e.g. with the registered drug Ocaliva®.
You should be aware that unknown adverse effects may occur during the study. However, with the doses used in this study no serious side effects are expected. 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 65 years old. Your body weight is at least 60 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 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 or are a light smoker.
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 till 18 days
- 0 times
- € 670,- until € 2.050,-
Groep A7€ 670,-
5 days stay
- 5 Sep 2018 up to and including 9 Sep 2018
Group B4€ 2.050,-
18 days stay
- 6 Sep 2018 up to and including 23 Sep 2018
Groep A8€ 670,-
5 days stay
- 26 Sep 2018 up to and including 30 Sep 2018
Group B5€ 2.050,-
18 days stay
- 27 Sep 2018 up to and including 14 Oct 2018
Group B6€ 2.050,-
18 days stay
- 18 Oct 2018 up to and including 4 Nov 2018