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- Your body weight must be at least 60 kg and your Body Mass Index (BMI) is between 18 and 28 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
- Both non-smokers and smokers are allowed to participate in this study; however, during your stay in the research facility, smoking is not allowed.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of €1709,- for participation in one of the groups.
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
The study consists of 1 period during which you will stay in our research facility in Groningen, Martini location for 14 days (13 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-179931
Type of study
The purpose of the study is to investigate to what extent the study medication is safe and tolerated. In addition, the combination (an existing drug in another form of administration together with a registered product) and the interaction between these two agents will also be investigated.
The study drug is not registered as a drug and in this new formulation is 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
The actual study will consist of 1 period during which you will stay in the clinical research center in Groningen, location Martini for 14 days (13 nights). Before and after the study you will visit the medical screening centre in Groningen, location Martini. You will receive the new formulation once in the form of suspension on day 1. On day 2 – 11 you will receive the registered compound once daily as a tablet and on day 12 you will receive both compounds. Blood samples will be taken regularly during the study.
Risks and medical supervision
The new formulation is a compound that may eventually be used for the treatment of narcolepsy. Narcolepsy is a sleeping disorder that involves excessive daytime sleepiness. For some people with narcolepsy it also involves a sudden loss of muscle tone (cataplexy), usually triggered by strong emotion. This dosing schedule is considered inconvenient for the patients because they have to wake up in the middle of the night to take the second dose.
The new formulation contains the same active molecule or substance, but in a special formulation which provides slower and longer release of the active substance. In a previous study the reported side effects included upper abdominal pain, nausea, stuffy nose, dizziness, joint pain and sore throat. All of these side effects were reported as being either mild or moderate and these side effects resolved quickly without any long-term effects noted.
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 with a white or slightly tinted skin; the reason that only people with a white or slightly tinted skin can participate is that some medication might act differently depending on race. Your age is between 18 and 55 years old and you can only take part in the study if you do not smoke or smoke average. Smoking in the clinic is not allowed.
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 are allowed to take part in the study, you will be medically screened; this screening will take place within three weeks before the start of the study.
- Period of stay
- 14 days
- 0 times
- € 1.709,-
Group 1€ 1.709,-
14 days stay
- 29 Mar 2018 up to and including 11 Apr 2018
Group 2€ 1.709,-
14 days stay
- 15 Apr 2018 up to and including 28 Apr 2018
Group 3€ 1.709,-
14 days stay
- 29 Apr 2018 up to and including 12 May 2018