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- You are healthy.
- You are a non-smoker.
- Your body weight must be at least 60 kg and your Body Mass Index (BMI) is between 20 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters,
- You have never been addicted to recreational drugs.
- Women are only allowed to participate in this study if:
- they are using adequate contraception
- or have been postmenopausal for at least two years
- or have been surgically sterilized
- To determine if you are suitable to participate in this study, you will undergo a medical screening
You will receive a gross compensation of €1418,- for participation in one of the groups of Part 2.
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 (location Martini) for
13 days (12 nights).
Please note: You have to be available for all dates for the group to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
Narcolepsy is a sleeping disorder that involves excessive daytime sleepiness and, in some patients, a sudden
loss of muscle tone usually triggered by strong emotion (cataplexy).
Information sheet PRA-173371 (part 2)
Type of study
Soon a research study will start at PRA of an experimental drug for the treatment of narcolepsy, a medical condition characterized by excessive daytime sleepiness. The purpose of the study is to investigate how quickly and to what extent the experimental drug is absorbed and eliminated from the body. The comparison is called relative bioavailability. The safety and to what extent the experimental drug is tolerated will also be investigated. The experimental drug is not registered as a drug and will be given to humans for the first time. The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The study consists of 2 parts. You are being recruited for Part 2, which will consist of 1 period during which you will stay in our clinical research facility in Groningen (location Martini) for 9 days (8 nights). Before the start of the study you will visit the medical screening center, location Martini.
For Part 2, you will receive during this trial 4 treatments that consists of the new drug administered orally as a mixture of small pellets approximately 1mm diameter, that contain the same active ingredient and 1 treatment with an existing compound as an oral solution every other day for 8 days.
Each of the formulations contains granules which will be taken dry by mouth. These granules are developed such that the active compound is slowly distributed over the body after intake (delayed release [DR] or sustained release [SR]). Each dose of granules is washed down by an oral solution of the experimental drug. This oral solution is developed such that the active compound is immediately absorbed by the body after intake (immediate release [IR]) to elicit sleep. The dose of the experimental drug in the granules and oral solution is different for each formulation Each volunteer will receive each treatment once, the order in which the treatments will be given will be determined by chance.
Blood samples will be taken regularly. Also, your alertness during the first 4 hours after the administration will be checked.
Risks and medical supervision
The experimental drug is being evaluated for the treatment of narcolepsy. Narcolepsy is a sleeping disorder that involves excessive daytime sleepiness, and, in some patients, a sudden loss of muscle tone usually triggered by strong emotion (cataplexy). One of the current medications for excessive daytime sleepiness and cataplexy in narcolepsy is an oral solution (registered drug) that contains a high amount of sodium at the highest approved dose. The active substance of the registered drug has depressant or sedating effects in people.
All drugs have the potential to cause adverse events. The extent to which this occurs differs by investigation. In clinical studies with the registered compound in subjects with narcolepsy, the most common adverse effects were nausea, dizziness, vomiting, somnolence (sleepiness), enuresis (inability to control urination especially during sleep), and tremor (muscle twitching). Overall, the adverse effects observed in clinical studies with healthy volunteers are similar to those seen in patients. You will be under strict medical supervision during the study. Due to possible extended release effect of the experimental drug, we strongly advise you travel home by public transport or to have someone pick you up after your discharge from the clinical research facility, since you may not be fit enough to drive a car.
Conditions for participation
You are a healthy male or female between 18 and 45 years old. You can only take part in the study if you do not smoke, never have been addicted to recreational drugs and if you are able to fast for at least 10 hours before eating a standardized high-fat, high-calorie breakfast and 6 hours more after taking the study drug. Participants must use adequate measures to prevent any pregnancy during the entire study and for 3 months (90 days) after completing the study. Women must use medically acceptable methods of contraception (birth control), be post-menopausal for at least two years or be surgically sterile. Males must use adequate contraception throughout the entire study period and for 90 days after the subject completes the study. Males may not donate sperm for 3 months (90 day) after completing the 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 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
- 9 days
- 0 times
- € 1.418,-
Groep 2-2€ 1.418,-
9 days stay
- 5 Sep 2018 up to and including 13 Sep 2018
Groep 2-3€ 1.418,-
9 days stay
- 13 Sep 2018 up to and including 21 Sep 2018
Groep 2-1€ 1.418,-
9 days stay
- 20 Aug 2018 up to and including 28 Aug 2018