PRA-170121

Central nervous system conditions

Study of a new compound that is being developed for the treatment of central nervous system conditions (including epilepsy)

Particulars

  • You must speak and understand English or Dutch to participate.
  • 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 intrauterine device or hormonal contraceptives in combination with a condom or have been postmenopausal for at least one year or have been surgically sterilized.
  • You are advised not to drive, use machinery or take part in any dangerous activity from the first administration of the study compound until the follow-up visit.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
  • To participate you have to live or reside in the Netherlands during the study
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Compensation

You will receive a gross compensation of € 697,- for participation in one of the groups of part A of this study.

For participation in one of the groups of part B of the study, you will receive a gross compensation of € 2.536,-.

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 Part A the study consists of 1 period during which you will stay in our research facility in Groningen for 4 days (3 nights), followed by 2 short visits.

For Part B the study consists of 2 periods. During the first period you will stay in our research facility in Groningen for 4 days (3 nights), followed by 3 short visits. During the second period you will stay in our research facility in Groningen for 11 days (10 nights).

The follow-up visit for Part A is between 5-10 days after dosing, for Part B this will be between 7-10 days after dosing.

Please note: The dates of the study may be subject to change. You have to be available for all dates to be able to participate in this study.

Have you participated in a medical trial before?  Then be aware that there needs to be a period of 3 months between follow up of the previous study to dosing of this study.

The medical screening for this study will take place in the screening center in Groningen or Utrecht.

For more information in about researches and a complete overview of the scheduled study dates please refer to our website in English, or German.

More info

Type of study

The purpose of the study is to investigate how quickly and to what extent the study drug is absorbed and eliminated from the body. It will also be investigated how safe the study drug is and how well it is tolerated when it is administered to healthy volunteers. In addition, the effect of your genetic information on how the body responds to the study drug will be investigated.

In Part A the study drug will be tested at various dose levels after a normal meal and may also be administered to healthy volunteers after a high-fat meal (Group A5 only).  

In Part B the study drug will be tested when it is given in multiple doses.  It will also be investigated when it is administered together with midazolam. Midazolam is a drug that is used for the treatment of insomnia.

The study drug has been given to healthy volunteers and patients 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 the study consists of 1 period during which you will stay in our research facility in Groningen for 4 days (3 nights), followed by 2 short visits. Volunteers participating in Group A1 to Group A4 will receive the study drug or placebo (a medicine without any active ingredient) after a standardized meal. Volunteers participating in Group A5 may receive the study drug or placebo after a standardized normal or high-fat meal.  

For Part B the study you will stay in our research facility for 2 separate periods. During the first period you will stay in our research facility in Groningen for 4 days (3 nights), followed by 3 short visits. During the second period you will stay in our research facility for 11 days (10 nights). You will receive the study drug or placebo for 24 days. On 2 days, you will receive Midazolam as well.  

Whether you receive the study drug or placebo will be determined by chance.  Blood samples will be taken regularly during the study. In addition, urine will be collected in the 24 hours after the administration of the study drug or placebo on Day 25 in Part B.  

Risks and medical supervision

The study drug is being developed for the treatment of central nervous system conditions (including epilepsy) associated with neurodevelopmental disorders such as Rett syndrome and autism spectrum disorder. The other drug that will be given in Part B of the study is midazolam. Midazolam is a drug that is used for insomnia and as a sedative.

The study drug may cause side effects. It has been given to healthy volunteers and patients before and was well tolerated at all dose levels. The most frequently reported side effects were headache and diarrhoea. The most frequently reported side effects of midazolam (only administered in Part B) are nausea, vomiting, skin rash, agitation and prolonged sleepiness.

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. 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 4 weeks before the start of the study.

You are advised not to drive, use machinery or take part in any dangerous activity from the first administration of the study compound until the follow-up visit.

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Groups

Group B1b

Full

4 days en 11 days stay

  • 4 Mar 2019 up to and including 7 Mar 2019
  • 24 Mar 2019 up to and including 3 Apr 2019

short visit

  • 15 Mar 2019
  • 17 Mar 2019
  • 22 Mar 2019
€ 2.536,- Select

Group A5

Full

4 days stay

  • 5 Feb 2019 up to and including 8 Feb 2019

short visit

  • 9 Feb 2019
  • 10 Feb 2019
€ 697,- Select

Group B1a

Full

4 days en 11 days stay

  • 25 Feb 2019 up to and including 28 Feb 2019
  • 17 Mar 2019 up to and including 27 Mar 2019

short visit

  • 8 Mar 2019
  • 10 Mar 2019
  • 15 Mar 2019
€ 2.536,- Select