PRA-184881

Central nervous system conditions and neurodevelopmental disorders

Study of a new compound that is being developed for the treatment of central nervous system conditions and neurodevelopmental disorders (such as epilepsy and autism)

Particulars

  • You are between 18 and 60 years old
  • You do not smoke. 
  • Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
  • Women are only allowed to participate in this study if they are using sufficient contraception such as an intrauterine device or hormonal contraceptives in combination with a condom, or have been postmenopausal for at least one year, or have been surgically sterilized at least 6 months ago.
  • You are only allowed to participate, if you did not participate in a drug study within the 3 months prior to the first dosing in this study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening. 
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Compensation

You will receive a gross compensation of € 2.524,- for participation in part B (group 2) of the 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

The study consists of 2 parts. You can only participate in one part.

For Part A (group 1) the study consists of 4 periods. For each period, you will stay in our research facility in Groningen for 7 days (6 nights).

For Part B (group 2) the study consists of 3 periods. For each period, you will stay in our research facility in Groningen for 7 days (6 nights).

Finally, there will be a follow-up visit for both groups 14 days after the dosing of the last period of your group.

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.

More info

Type of study

Soon a research study will start at PRA for a compound which is being developed for the treatment of central nervous system conditions and neurodevelopmental disorders (such as epilepsy and autism). This study will be performed in up to 24 healthy male and female volunteers. The study will be performed in 2 parts, Part A and Part B. The main purpose of this study is to investigate how quickly and to what extent the compound is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). The pharmacokinetics of the compound administered as 3 different types of capsules will be compared to the pharmacokinetics of the compound administered as oral solution. The effect of a normal breakfast and a high-fat breakfast on the pharmacokinetics of the compound, administered as 1 type of capsule, will be investigated as well. It will also be investigated how safe the compound is and how well it is tolerated. Finally, the effect of your genetic information on how your body responds to the compound will be investigated; this is a mandatory part of this study. The study drug has been given to healthy volunteers before, but it is not registered as a drug. This 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 1) the study consists of 4 periods. For each period, you will stay in our research facility in Groningen for 7 days (6 nights). The compound will be administered as a single dose in 4 treatment periods: once as an oral solution and 3 times as capsules. The type of capsule differs between the treatment periods. Which treatment you will receive in which period will depend on which of the 4 treatment sequences you are assigned to. For Part B (group 2) the study consists of 3 periods. For each period, you will stay in our research facility in Groningen for 7 days (6 nights). The compound will be administered as a single dose in 3 treatment periods: once under fasted conditions, once after a normal breakfast and once after a high-fat breakfast. The type of capsules to be used will be determined based on the results of Part A of the study. The type of breakfast (or no breakfast at all) you will be given per period will depend on which of the 6 treatment sequences you are assigned to. Between 10 and 14 days after the last study drug administration your health will be checked for the last time during the follow-up visit. The appointment for this follow-up visit will be made during the study (not on the weekend). Blood samples will be taken regularly during the study.

Risks and medical supervision

The study compound may cause side effects. The compound administered to healthy volunteers was well tolerated at all doses. The most common side effects reported by people who have taken the compound in a previous study were diarrhea and feeling sleepy. The study compound may also have side effects that are still unknown. 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 and between 18 and 60 years old. You can only take part in the study if you do not smoke. Females are only allowed to participate in this study if they are using sufficient contraception such as intrauterine device or hormonal contraceptives in combination with a condom or have been postmenopausal for at least one year or have been surgically sterilized for a minimum of 6 months. The study will be conducted 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 and from doing any strenuous activity / exercise. 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 4 weeks before the start of the study.

Compensation

You will receive a gross compensation of € 3320,- for participation in part A (group 1) of this study. For participation in part B (group 2) of the study, you will receive a gross compensation of € 2524,-. 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.

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Groups

Group 1

Full

4× 7 days stay

  • 8 Apr 2019 up to and including 14 Apr 2019
  • 22 Apr 2019 up to and including 28 Apr 2019
  • 6 May 2019 up to and including 12 May 2019
  • 20 May 2019 up to and including 26 May 2019
€ 3.320,- Select

Group 2

Full

3× 7 days stay

  • 14 Jul 2019 up to and including 20 Jul 2019
  • 28 Jul 2019 up to and including 3 Aug 2019
  • 11 Aug 2019 up to and including 17 Aug 2019
€ 2.524,- Select