Study of a new formulation of an existing drug that is being developed for the treatment of excessive daytime sleepiness (narcolepsy)
- You are Caucasian (you have a light skin color)
- 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 must not participate.
- Both non smokers and smokers can participate, but you need to be able to abstain from smoking and
using nicotine containing products during your stay in the clinical center.
- To determine if you are eligible to participate in this study, you will undergo a medical screening.
You will receive a gross compensation of € 810,- 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, irrespective of the method of transportation.r.
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 2 days (1 night).
The follow-up visit will be conducted 3 – 5 days after the last dose in period
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
Soon a research study will start at PRA with a new formulation of an existing drug that may eventually be used for the treatment of excessive daytime sleepiness (narcolepsy). For some patients this comes with a sudden loss of muscle tone, usually triggered by strong emotions (cataplexy). The purpose of the study is to investigate how quickly and to what extent two different production batches of the study medication are absorbed and eliminated from the body and also will be investigated to what extent the study medication is tolerated. 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 the study medication once in each period. 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 both batches will be determined by chance. The actual study will consist of two periods of 2 days (1 night) 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 in Groningen (location Martini). 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 registred drug was also administrated, as well as the study medication with a slightly different composition than the medication used in the current study. All the tested medications were generally well tolerated. You should be aware that still unknown adverse effects may occur during the study.
In a study with the registred drug in patients with narcolepsy, the most common side effects were: dizziness, nausea and headache. In healthy volunteers exposed to the study drug, the most frequently reported effect was upper abdominal pain and nausea.
To approach the dosing regimen in patients as much as possible, dosing will be done late in the evening
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 Caucasian male or female between 18 and 65 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. Since the metabolism of the drug in the body can vary based on ethnicity, only Caucasian volunteers can participate. This means, you belong to or originates from one of the original people of Europe, the Middle east or North Africa, or the Indian subcontinent.
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 (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× 2 days stay
- 9 okt 2017 up to and including 10 okt 2017
- 16 okt 2017 up to and including 17 okt 2017
2× 2 days stay
- 10 okt 2017 up to and including 11 okt 2017
- 17 okt 2017 up to and including 18 okt 2017
2× 2 days stay
- 11 okt 2017 up to and including 12 okt 2017
- 18 okt 2017 up to and including 19 okt 2017
2× 2 days stay
- 23 okt 2017 up to and including 24 okt 2017
- 30 okt 2017 up to and including 31 okt 2017
2× 2 days stay
- 24 okt 2017 up to and including 25 okt 2017
- 31 okt 2017 up to and including 1 nov 2017