Study of a new compound that is being developed for the treatment of non-alcoholic steatohepatitis (NASH)
- You are between 18 and 50 years old.
- You do not smoke.
- Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m2.
- As a female you are allowed to participate in this study if you use adequate contraception. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom. Also, total abstinence, in accordance with the lifestyle of the subject, is acceptable. Females can only participate is they have been postmenopausal for at least one year or have been surgically sterilized.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
- After the study, the follow-up visit will follow, which will take place during the last short visit.
For participation in group B1 of the study, you will receive a gross compensation of €1555,- .
And for participation in group C1, C2 or C3 you will receive a gross compensation of €1526,- .
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 Group B1, the study consists of 2 periods during which you will stay in our research facility for each period for 6 days (5 nights). Each period will be followed by one short visit.
For Group C1, C2 and C3, the study consists of 1 period during which you will stay in our research facility for 11 days (10 nights), followed by one short visit.
The follow-up visit will take place during the last short visit.
Please note: Please see our website for the currently planned dates; however, these may be subject to change. You have to be available for all dates to be able to participate in this study.
Have you participated in a medical trial before? Then be aware that there needs to be a period of 60 days between the follow up of the previous study to dosing of this study.
The medical screening for this study will take place in the screening center in Groningen or Utrecht.
Type of study
The purpose of the study is to investigate how safe the study drug is and how well it is tolerated when it is administered to healthy volunteers.
In Part A it will also be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body and what the effect of the study drug on the body is.
In Part B it will also be investigated how food affects how quickly and to what extent the study drug is absorbed and eliminated from the body, and it will be investigated what the effect of the study drug is on the body when it is administered with and without food.
In Part C it will also be investigated how quickly and to what extent the study drug is absorbed and eliminated from the body with repeated dosing and what the effect of the study drug on the body is.
The study drug is not registered as a drug and has not been administered 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
For Part A the study will consist of 3 periods. For period 1 you will stay in the research center for 6 days (5 nights). During period 2 and 3 you will stay in the research center for a minimum of 6 days (5 nights) and a maximum of 7 days (6 nights). Each period will be followed by one short visit. You will receive the study drug or placebo (a medicine that looks like the study drug, but without any active ingredient) once in each period. During which period you will receive the study drug or placebo will be determined by chance.
For Part B the study will consist of 2 periods. During each period you will stay in the research center for 6 days (5 nights), followed by one short visit for each period. In one period you will receive the study drug with a high-fat breakfast and in one period you will receive the study drug without a breakfast. The order in which this occurs is determined by chance.
For Part C the study consists of 1 period during which you will stay in the research center for 11 days (10 nights), followed by one short visit. You will receive the study drug or placebo once daily for 7 days. Whether you receive the study drug or placebo will be determined by chance.
Blood samples will be taken regularly during the study. If you take part in Part B of the study, you will receive a high-fat breakfast once. This breakfast should be eaten within 30 minutes and consists of 2 fried eggs, 40 grams of bacon, 115 grams of fried potatoes, 2 slices of bread with 15 grams low fat margarine and 1 glass of whole milk. For vegetarians the bacon may be replaced by brie.
Risks and medical supervision
Non-alcoholic fatty liver disease (NAFLD) is the accumulation of fat in the liver not caused by excessive alcohol consumption. Some NAFLD patients also develop inflammation in the liver, this is called non-alcoholic steatohepatitis (NASH). The inflammation leads to damage and scar tissue (fibrosis) in the liver. This results in a higher risk for developing liver cirrhosis, cancer and eventually liver failure. The study drug is a new compound that may eventually be used for the treatment of NASH. The study drug prevents a signalling substance that is released with cell damage or after inflammation, lack of oxygen and cancer, from binding to a specific receptor that is increased in inflamed and cancerous cells. Therefore, the study drug is expected to block the actions of this signalling substance and thus stop the worsening of NASH or even reduce fibrosis in the liver.
The study drug may cause side effects, but because it will be administered to humans for the first time in this study, no side effects are known to date. 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 18 and 50 years of age. You can only take part in the study if you do not smoke. Women must use acceptable methods of contraception (i.e. hormonal contraceptives, such as the pill, combined with a condom), or they must have been surgically sterile, or they must have been postmenopausal for at least 12 months in order to participate in this study. 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.
2× 6 days stay
- 3 jun 2019 up to and including 8 jun 2019
- 13 jun 2019 up to and including 18 jun 2019
- 20 jun 2019
11 days stay
- 18 jun 2019 up to and including 28 jun 2019
- 2 jul 2019
11 days stay
- 11 jul 2019 up to and including 21 jul 2019
- 25 jul 2019
11 days stay
- 4 aug 2019 up to and including 14 aug 2019
- 18 aug 2019