PRA-176161 Psoriasis tot € 2.157,-

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Description

Study of a new compound that is being developed for the treatment of psoriasis

Requested participants

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

Duration and visits

  • 8 -17 days stay
  • 2 until 3 short visits

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Research details

Particulars

  • You are a non-smoker
  • Your body weight is between 55 – 105 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 height in meters.
  • Women 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 € 1.166,- for participation in Group A1a to A5a. For participation in Group A7, you will receive a gross compensation of € 4.272,-.

You will receive a gross compensation of €2157,- for participation in one of the B-groups

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 Group A1a to A5a the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 8 days (7 nights), followed by 2 short visits.

For Group A7 the study consists of 3 periods during which you will stay in our research facility in Groningen (Martini site) for 8 days (7 nights) each period and each period will be followed by 2 short visits.

For Group B1 to B4c the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 17 days (16 nights), followed by 3 short visits.

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-176161

Type of study

The study will be carried out by PRA in two parts: Part A and Part B. Part C of the study will be a multi-site study in patients with psoriasis.

Part A.

The purpose of this study is to investigate how safe the new compound is when it is administered as a single dose to healthy subjects. It will also be investigated how quickly and to what extent the new compound is absorbed and eliminated from the body. In one of the groups of Part A, it will also be investigated how quickly and to what extent the new compound is absorbed when it is administered in another dosage form and whether this will be influenced by food. In addition, the effect of the new compound on the body will be investigated. The effects of the new compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine. The study drug is not registered as a drug and has not been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.

Part B.

The purpose of this study is to investigate how safe the new compound is when it is administered as multiple doses to healthy subjects. It will also be investigated how quickly and to what extent the new compound is absorbed and eliminated from the body. In addition, the effect of the new compound on the body will be investigated. The effects of the new compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine. The study drug is not registered as a drug and has not 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

Part A:

For Group A1 to A5 the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 8 days (7 nights), followed by 2 short visits. You will receive the new compound or placebo once as a drink.

For Group A7 the study consists of 3 periods during which you will stay in our research facility in Groningen (Martini site) for 8 days (7 nights). Every period will be followed by 2 short visits. You will receive the new compound once in every period and no placebo will be given. In the first two periods you will receive the new compound when you are fasted, in the last period you will receive the new compound after a high-fat standardized breakfast.

Blood samples will be taken regularly and urine will be collected during the study. In addition, your heart rhythm will be monitored with a holter on the day of the administration of the new compound

Part B:

For Part B the study consists of 1 period during which you will stay in our research facility in Groningen (Martini site) for 17 days (16 nights), followed by 3 short visits. You will receive the new compound once daily for 14 days as a drink.

Blood samples will be taken regularly during the study. In addition, your heart rhythm will be monitored with a holter on 2 of the days on which the new compound will be given.

 

Risks and medical supervision

The new compound may eventually be used for the treatment of psoriasis and other (auto)immune disorders. In this type of disorder, the immune system is overactive. The new compound binds within cells in the body to a specific protein, that plays an important role in activating immune reactions. One part of these immune reactions is an increased production of specific signalling proteins such as interleukins. By binding to the specific protein within cells in the body, the new compound is able to counteract the effects of this protein. By doing so, it may decrease the production of interleukins. Experience with antibodies against interleukins have shown that by interfering with these interleukins a good clinical result can be obtained in immune disorders such as psoriasis and rheumatoid arthritis. The new compound can be taken by mouth, which is an important advantage over other treatments for the same diseases.

The study compound may cause side effects. As it is administered to humans for the first time in this study, side effects in humans have not been reported to date. Based on the mechanism of action of the new compound and its possible effects on the immune system, it is possible that you may be more susceptible to infections during participation in the study. You will be closely monitored for any signs and symptoms of infection and 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 old. You can only take part in the study if you do not smoke. Women 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 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 three weeks before the start of the study.

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Groep A5a

€ 1.166,-

8 days stay

  • 28 May 2018 up to and including 4 Jun 2018

short stay

Inapplicable

short visit

  • 6 Jun 2018
  • 8 Jun 2018

Group B1

€ 2.157,-

17 days stay

  • 4 Jun 2018 up to and including 20 Jun 2018

short stay

Inapplicable

short visit

  • 17 Aug 2018
  • 19 Aug 2018
  • 23 Aug 2018

Group B4a

€ 2.157,-

17 days stay

  • 4 Jun 2018 up to and including 20 Jun 2018

short stay

Inapplicable

short visit

  • 22 Jun 2018
  • 24 Jun 2018
  • 28 Jun 2018

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