PRA-180701 Mood and/or anxiety disorders tot € 2.370,-

Many places available

Description

Study of a new compound that is being developed for the treatment of mood and/or anxiety disorders

Requested participants

  • M/F, healthy, 18 - 55 years old
  • Non-smokers only

Duration and visits

  • 4 till 20 days stay
  • 0 until 1 short visits

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Research details

Particulars

  • You are a non-smoker.
  • Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • Please note: Females are only allowed to participate in this study if they have been postmenopausal for at least one year or if they have been surgically sterilized.
  • 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 € 567,- for participation in one of the groups of Part 1 (group 1a - 2b). For participation in one of the groups of Part 2 (group 3a - 4b) of the study, you will receive a gross compensation of € 2.370,- and for participation in one of the groups of Part 3 (group 5b - 6b) of the study, you will receive a gross compensation of € 1.249,-.

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 1 (group 1a - 2b) the study consists of 1 period during which you will stay in our research facility in Groningen. for 4 days (3 nights). For Part 2 (group 3a - 4b) the study consists of 4 periods whereby you will stay in our research facility in Groningen for 5 days (4 nights) for each period. For Part 3 (group 5b - 6b) the study consists of 1 period during which you will stay in our research facility in Groningen for 9 days (8 nights), followed by 1 short visit.

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.

Information sheet PRA-180701

Type of study

Soon a research study will start at PRA with a new drug for the treatment of mood and/or anxiety disorders The study will be performed in 3 parts. The purpose of Part 1 of the study is to investigate how safe the new drug is and how well it is tolerated when it is administered in single doses to healthy volunteers. It will also be investigated how quickly and to what extent the drug is absorbed by and eliminated from the body. The purpose of Part 2 is to investigate how quickly and to what extent the drug is absorbed by and eliminated from the body (pharmacokinetics) when administered as an oral solution compared to an oral capsule. In addition, the effect of food on the pharmacokinetics of the drug will be investigated. It will also be investigated how safe the new compound is and how well it is tolerated when it is administered to healthy volunteers. The purpose of Part 3 is to investigate how safe the new drug is and how well it is tolerated when it is administered as multiple doses to healthy volunteers. It will also be investigated how quickly and to what extent the drug is absorbed by and eliminated from the body. The study drug is not registered as a drug, but it has been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

For Part 1 the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 4 days (3 nights). During this period, you will receive the study drug or placebo (a medicine without any active ingredient; a fake medicine) once as an oral solution. Whether you will receive the drug or placebo will be determined by chance. For Part 2 the study consists of 4 periods during which you will stay in our research facility in Groningen (Martini site) for 5 days (4 nights) for each period. In each period you will receive the study drug once per period. The drug will be given as an oral solution in 1 period and as an oral capsule in 3 periods. When the drug is administered as an oral capsule, you will receive it once when you have fasted for at least 10 hours, once with a high-fat, high-calorie breakfast and once with a standardized breakfast. Each treatment will be given once, the order in which you receive the treatment will be determined by chance. For Part 3 the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 9 days (8 nights), followed by 1 short visit. You will receive the study drug or placebo (a medicine without any active ingredient; a fake medicine) once daily for 7 consecutive days. Whether you will receive the drug or placebo will be determined by chance. Blood samples will be taken regularly during the study. In addition, your heart rhythm will be monitored continuously on certain days during the study via telemetry. For Part 1, the follow-up visit will take place 5 – 12 days after your departure from the clinic. The follow-up visit for Part 2 will take place on the day of departure from the last study period. For Part 3, the follow-up visit will take place 13 – 20 days after your departure from the clinic.

Risks and medical supervision

The drug is a new drug that is being investigated for the treatment of people with mood and/or anxiety disorders. It might normalize certain mechanisms in the brain that cause anxiety (for example panic attacks) without causing sleepiness or reduced awareness. All potential drugs cause side effects; the extent to which this occurs differs. This is the 4th study with the new drug. Preliminary data from the previous studies show no significant side effects. Side effects most frequently reported by the participants in those studies were headache and 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 between 18 and 55 years of age. You can only participate in the study if you do not smoke. Females are only allowed to participate in this study if they have been postmenopausal for at least one year or if they 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 is not allowed during the study. 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.

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Group 1b1

€ 567,-

4 days stay

  • 26 Sep 2018 up to and including 29 Sep 2018

short stay

Inapplicable

short visit

Inapplicable

Group 2a

€ 567,-

4 days stay

  • 7 Oct 2018 up to and including 10 Oct 2018

short stay

Inapplicable

short visit

Inapplicable

Group 2b

€ 567,-

4 days stay

  • 8 Oct 2018 up to and including 11 Oct 2018

short stay

Inapplicable

short visit

Inapplicable

Group 5a

€ 1.249,-

9 days stay

  • 21 Oct 2018 up to and including 29 Oct 2018

short stay

Inapplicable

short visit

  • 30 Oct 2018

Group 5b

€ 1.249,-

9 days stay

  • 22 Oct 2018 up to and including 30 Oct 2018

short stay

Inapplicable

short visit

  • 31 Oct 2018

Group 3a

€ 2.370,-

4 times 5 days stay

  • 28 Oct 2018 up to and including 1 Nov 2018
  • 4 Nov 2018 up to and including 8 Nov 2018
  • 11 Nov 2018 up to and including 15 Nov 2018
  • 18 Nov 2018 up to and including 22 Nov 2018

short stay

Inapplicable

short visit

Inapplicable

Group 3b

€ 2.370,-

4 times 5 days stay

  • 4 Nov 2018 up to and including 8 Nov 2018
  • 11 Nov 2018 up to and including 15 Nov 2018
  • 18 Nov 2018 up to and including 22 Nov 2018
  • 25 Nov 2018 up to and including 29 Nov 2018

short stay

Inapplicable

short visit

Inapplicable

Group 4a

€ 2.370,-

4 times 5 days stay

  • 12 Nov 2018 up to and including 16 Nov 2018
  • 19 Nov 2018 up to and including 23 Nov 2018
  • 26 Nov 2018 up to and including 30 Nov 2018
  • 3 Dec 2018 up to and including 7 Dec 2018

short stay

Inapplicable

short visit

Inapplicable

Group 6a

€ 1.249,-

9 days stay

  • 14 Nov 2018 up to and including 22 Nov 2018

short stay

Inapplicable

short visit

  • 23 Nov 2018

Group 6b

€ 1.249,-

9 days stay

  • 15 Nov 2018 up to and including 23 Nov 2018

short stay

Inapplicable

short visit

  • 24 Nov 2018

Group 4b

€ 2.370,-

4 times 5 days stay

  • 19 Nov 2018 up to and including 23 Nov 2018
  • 26 Nov 2018 up to and including 30 Nov 2018
  • 3 Dec 2018 up to and including 7 Dec 2018
  • 10 Dec 2018 up to and including 14 Dec 2018

short stay

Inapplicable

short visit

Inapplicable

Group 1a

€ 567,-

4 days stay

  • 23 Sep 2018 up to and including 26 Sep 2018

short stay

Inapplicable

short visit

Inapplicable
Group full

Group 1b

€ 567,-

4 days stay

  • 24 Sep 2018 up to and including 27 Sep 2018

short stay

Inapplicable

short visit

Inapplicable
Group full

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