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- You are a non-smoker
- Your Body Mass Index (BMI) is between 19 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
- Women are only allowed to participate in this study if they are using sufficient hormonal contraception or 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.
- For Groups A3, A4, A5, B3, B4, B5 and C1 an EEG will be made as part of the screening. After preliminary approval, an additional appointment will be made to make an EEG at the Martini Hospital in Groningen. An EEG is a painless procedure in which small flat metal discs are glued to your scalp. It is intended to measure the electrical activity in your brain.
For participation in Group B5 you will receive a gross compensation of €976,-
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 Part B, the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for 6 days (5 nights).
Please note: You have to be available for all dates 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.
Information sheet PRA-173981
Type of study
The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body (this is called pharmacokinetics [PK]). In addition, the effect of a placebo will be investigated.
A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.
The study drug is not registered as a drug and has not been given 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 (Group A1a – A5) the actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location UMCG for 4 days (3 nights).
For Part B (Group B1 – B5), the actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location UMCG for 6 days (5 nights).
For Part C (Group C1) the actual study will consist of 2 periods during which you will stay in the clinical research center in Groningen, location UMCG for 4 days (3 nights) in each period.
Before the start of the study you will visit the medical screening centre in Groningen.
An EEG as part of the screening for groups A3, A4, A5, B3, B4, B5 and C1
As part of the screening an EEG will be made only for Groups A3, A4, A5, B3, B4, B5 and C1. Means after preliminary approval, an additional appointment will be made to make an EEG at the Martini Hospital in Groningen. An EEG is a painless procedure in which small flat metal discs are glued to your scalp. It is intended to measure the electrical activity in your brain.
In Part A, you will receive the study drug and or placebo once in an oral dose.
In Part B, you will receive the study drug and or placebo once daily in oral dose on day 1, 2, 3 and 4.
In Part C, you will receive the study drug once daily in oral dose on day 1 and 7. On day 1 and 2 without a breakfast and on day 7 and 8 after a high fat breakfast.
Blood samples will be taken and urine will be collected regularly during the study. In addition, telemetry will be done on day 1, different questionnaires for your reaction, mood and alertness and the body sway (balance test) will be measured on every in-house day
Risks and medical supervision
All potential drugs cause adverse effects; the extent to which this occurs differs. As the new compound will be administered to man for the first time in this study, side effects in man have not been reported to date. However, the compound has been studied in animals. It was found to be well-tolerated in rats (at dose level of 30 mg per kg body weight per day) and dogs (at dose level 20/10 mg per kg body weight per day). The most frequently observed side effects in animals were: increased heart rate, changes in respiration, and central nervous system stimulation.
There is available information on an agent with a similar mechanism of action. The study drug was evaluated in 36 patients with multiple tumor indications with no serious adverse events. The mild and moderate adverse events that occurred in 5% or more of the patients were fatigue, nausea, pruritus (itching), constipation, dizziness, hypertension and fever.
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. You can only take part in the study if you do not smoke. Women must be surgically sterile or post-menopausal for at least 1 year or use acceptable methods of hormonal contraception (birth control) 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) and grapefruit (juice) 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 are allowed to 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
- 6 days
- 0 times
- € 976,-
Group B5€ 976,-
6 days stay
- 1 Apr 2018 up to and including 6 Apr 2018