Study of a new formulation of an existing drug that is being developed for the treatment of excessive daytime sleepiness (narcolepsy)
- You are Caucasian
- Your weight is at least 60 kg and your Body Mass Index (BMI) is between 18 and 28 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
- Women are only allowed to participate in this study if they are using sufficient contraception (for example hormonal contraceptives or intrauterine device) or if they have been postmenopausal for at least one year or if they have been surgically sterilized.
- Women who are breastfeeding or pregnant can not participate.
- Both non smokers and smokers can participate, but smoking is not allowed during your stay in the clinical center.
- To determine if you are suitable to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 796,- for full participation in one of the groups of this study.
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 each group the study consists of 2 periods, for each period you will stay in our research facility in Groningen (location Martini) for 3 days (2 nights). The follow-up visit will be conducted 4 – 5 days after the last dose in period 2.
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.
Type of study
The purpose of the study is to investigate how quickly and to what extent the study medication is absorbed and eliminated in the body compared to a comparable registered medication and to assess the safety and tolerability of the study medication. This study is not intended to improve your health, but is necessary for the further development of this study medication. The study medication is not registered as a drug, but has been given to humans before, in both past and current ongoing studies. This study medication is a new formulation of an existing drug with another formulation of the same active compound which is already registered as a drug and marketed for narcoleptic patients in Europe and in the US.
The study will only take place after it has been approved by the Independent Ethics Committee.
Setup and duration of the study
The study will consist of 2 treatment periods in which you will receive in one period the study medication and in the other period the registered medication. The medication will be given as an oral suspension. During the study you will receive the study medication in the evening, before going to bed, two hours after a meal. The order in which you will receive the study medication or the registered medication will be determined by chance. The actual study will consist of two periods of 3 days (2 nights) each during which you will stay in the 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. The active substance of the study medication is the same as the active substance of a currently registered drug. In a previous study the study medication, as well as the study medication with a slightly different composition than the medication used in the current study and the registred drug was administrated. All the tested medications were generally well tolerated by healthy volunteers, given as an single administration of a maximum of 7.5 gram. You should be aware that still unknown adverse effects may occur during the study.
In a previous study with the study medication in healthy volunteers the following side effects were reported: somnolence, (deep) sleep, abdominal pain, nausea, stuffy nose, dizziness, joint pain and sore throat. These side effects were reported as being either mild or moderate and these side effects resolved quickly. The side effects of the study medication were similar as the registered medication.
The most commonly reported adverse reactions in patients with narcolepsy who use the registered medication are: dizziness, nausea and headache. 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 with a white or slightly tinted skin between 18 and 55 years old. Your body weight is at least 60 kg and your Body Mass Index (BMI) is between 18 and 28 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 or if you are able to abstain from smoking and using nicotine containing products from admission and during your stays in the clinical center. 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. Only people with a white or slightly tinted skin can participate in this study, the reason for this is that some medication might act differently depending on race.
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; this screening will take place within three weeks before the start of the study.
2× 3 days stay
- 27 nov 2017 up to and including 29 nov 2017
- 4 dec 2017 up to and including 6 dec 2017
2× 3 days stay
- 28 nov 2017 up to and including 30 nov 2017
- 5 dec 2017 up to and including 7 dec 2017
2× 3 days stay
- 11 dec 2017 up to and including 13 dec 2017
- 18 dec 2017 up to and including 20 dec 2017
2× 3 days stay
- 12 dec 2017 up to and including 14 dec 2017
- 19 dec 2017 up to and including 21 dec 2017