Study of a new investigational compound that may eventually be used for the treatment of cancer
- You do not smoke
- Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- Females are only allowed to participate in this study if you are using sufficient contraception (for example hormonal contraceptives or intrauterine device) or if you are postmenopausal for at least one year or if you are surgically sterilized.
- Women who are lactating or pregnant can not participate.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 763,- for full participation in one of the groups of A5, A6 or A7
You will receive a gross compensation of € 2.127,- 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, regardless of the mode of transportation.
Period of stay and research
For the groups A5 till A7 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 1 short visit to our research center (location Martini). An additional follow-up visit will be conducted 15 – 17 days after dosing.
For group B1 till B6 the study consists of 1 period were you will stay for 18 days (17 nights) in our research facility in Groningen (location Martini), followed by 1 short visit to our research center (location Martini). An additional follow-up visit will be conducted 28 – 30 days after the start of the 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.
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, eliminated and what the effect is on the the body. In addition, the effect of food will be investigated in group 4. 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 – A3 and group A5 – A7 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.
For group A4 the study consists of 1 or 3 periods of 5 days (4 nights). If you are participating in 1 or in all 3 study periods depends on whether you receive placebo (a fake medicine) during the first period. If you receive placebo during the first period, the study will end for you after you complete the requirements for the first study period. If you receive the study compound during the first period, the study will include another 2 study periods. Whether you will receive the study compound or placebo will be determinded by chance. During the first period you will receive the study compound once, after you have fasted for 10 hours. During the second and third period, you will receive an alternative formulation of the study compound after you have fasted for 10 hours in one period, and after a high-fat breakfast in the other period.
For part B, groups B 8-13, 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. The medication will be given as an oral capsule.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. The most frequently observed side effects of the highest doses tested in animals were: weight loss, decreased appetite, vomiting 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 18 and 55 years old. Your body weight is at least 50 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 in this study if you use a medically acceptable method of contraception (for example hormonal contraceptives or intrauterine device) or if you are postmenopausal for at least one year or if you are surgically sterilized. Women who are pregnant or breastfeeding are not eligible for participation.
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 four weeks before the start of the study.
18 days stay
- 6 aug 2018 up to and including 23 aug 2018
- 26 aug 2018