PRA-167171 White blood cells € 4.620,-

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Description

Study of a new compound that is being developed for the treatment of patients with a shortage of white blood cells.

Requested participants

  • M/F, healthy, 18 - 55 years old

Duration and visits

  • 21 days stay
  • 21 short visits

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Research details

Particulars

  • Your body weight must be at least 60 kg and your Body Mass Index (BMI) is between 19 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.
  • ​You have not participated in the PRA study with code 153651.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
  • When you want to participate in one specific group, please contact us as soon as possible; the latest possibility for a screening appointment is 2 weeks before the scheduled date of the first entry in our clinic for that group.
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Compensation

You will receive a gross compensation of €4.620,- for 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, regardless of the mode of transportation.

Period of stay and research

The study consists of 3 periods during which you will stay in our research facility in Groningen (location Martini). Each period consists of 7 days (6 nights). Each period will be followed by 7 short visits. In case it is necessary, we can arrange overnight stays in a B&B for the first 4 short visits for each period.

Information sheet PRA-167171

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 as compared to two already comparable registered drugs, one in the United States (US) and one in Europe (EU), after an injection under the skin. It will also investigate the effect of the study drug on the amounts of certain types of white blood cells and the possible development of antibodies in your body as compared to the effects of the registered drug. Finally it will be investigated to what extent the new drug is tolerated. This study is not intended to improve your health, but is necessary for the further development of the new study drug.
The new study drug has not been approved as a drug, but has been given to humans before in other studies. 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 3 periods during which you will receive one injection of the study drug, one injection of the drug registered in the US and one of the drug registered in EU. During these periods you will stay in the clinical research center in Groningen (location Martini) for 7 days (6 nights). Each period will be followed by 7 short visits and an additional call at the end of the study. Before the start of the study, you will undergo a medical screening in the Medical Screening Center Groningen (location Martini).

Blood samples will be taken regularly during the study

Risks and medical supervision

All potential drugs cause adverse effects; the extent to which this occurs differs. The study drug hasbeen studied before in research similar to the current study.

The following list represents many of the side effects known for the active component of the new study drug, reported by cancer patients who received multiple doses of this component to treat the side effects of chemotherapy. Because this study includes only healthy volunteers who will receive single doses of the new study drug and the two registered drugs in the US and EU, the probability of any of the following events to happen is considered low.

The most frequently observed adverse effects in man were: bone pain, and general aches and pains in the joints and muscles, nausea, headaches and pain and redness at the site of the injection. You should be aware that possibly other, still unknown adverse effects may occur during the study. However, with the doses used in this study serious adverse effects are uncommon. It should be emphasized that the most common side effects could still be present or may appear on the day you leave the clinical research center. 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 or smoke no more than 10 cigarettes per day. Your body weight must be at least 60 kg and your Body Mass Index (BMI) is between 19 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and length in meters.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, poppy seeds, cola, power drinks, chocolate (including products made of chocolate) and grapefruit (juice) 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 five weeks before the start of the study.

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Group 76

€ 4.620,-

21 days stay

  • 5 Feb 2018 up to and including 11 Feb 2018
  • 2 Apr 2018 up to and including 8 Apr 2018
  • 28 May 2018 up to and including 3 Jun 2018

short stay

Inapplicable

kort bezoek

  • 12 Feb 2018 up to and including 15 Feb 2018
  • 17 Feb 2018
  • 20 Feb 2018
  • 5 Mar 2018
  • 9 Apr 2018 up to and including 12 Apr 2018
  • 14 Apr 2018
  • 17 Apr 2018
  • 30 Apr 2018
  • 4 Jun 2018 up to and including 7 Jun 2018
  • 9 Jun 2018
  • 12 Jun 2018
  • 25 Jun 2018
Group full

Group 77

€ 4.620,-

21 days stay

  • 7 Feb 2018 up to and including 13 Feb 2018
  • 4 Apr 2018 up to and including 10 Apr 2018
  • 30 May 2018 up to and including 5 Jun 2018

short stay

Inapplicable

kort bezoek

  • 14 Feb 2018 up to and including 17 Feb 2018
  • 19 Feb 2018
  • 22 Feb 2018
  • 7 Mar 2018
  • 11 Apr 2018 up to and including 14 Apr 2018
  • 16 Apr 2018
  • 19 Apr 2018
  • 2 May 2018
  • 6 Jun 2018 up to and including 9 Jun 2018
  • 11 Jun 2018
  • 14 Jun 2018
  • 27 Jun 2018
Group full

Group 78

€ 4.620,-

21 days stay

  • 12 Feb 2018 up to and including 18 Feb 2018
  • 9 Apr 2018 up to and including 15 Apr 2018
  • 4 Jun 2018 up to and including 10 Jun 2018

short stay

Inapplicable

kort bezoek

  • 19 Feb 2018 up to and including 22 Feb 2018
  • 24 Feb 2018
  • 27 Feb 2018
  • 12 Mar 2018
  • 16 Apr 2018 up to and including 19 Apr 2018
  • 21 Apr 2018
  • 24 Apr 2018
  • 7 May 2018
  • 11 Jun 2018 up to and including 14 Jun 2018
  • 16 Jun 2018
  • 19 Jun 2018
  • 2 Jul 2018
Group full

Group 79

€ 4.620,-

21 days stay

  • 14 Feb 2018 up to and including 20 Feb 2018
  • 11 Apr 2018 up to and including 17 Apr 2018
  • 6 Jun 2018 up to and including 12 Jun 2018

short stay

Inapplicable

kort bezoek

  • 21 Feb 2018 up to and including 24 Feb 2018
  • 26 Feb 2018
  • 1 Mar 2018
  • 14 Mar 2018
  • 18 Apr 2018 up to and including 21 Apr 2018
  • 23 Apr 2018
  • 26 Apr 2018
  • 9 May 2018
  • 13 Jun 2018 up to and including 16 Jun 2018
  • 18 Jun 2018
  • 21 Jun 2018
  • 4 Jul 2018
Group full

Group 80

€ 4.620,-

21 days stay

  • 19 Feb 2018 up to and including 25 Feb 2018
  • 16 Apr 2018 up to and including 22 Apr 2018
  • 11 Jun 2018 up to and including 17 Jun 2018

short stay

Inapplicable

kort bezoek

  • 26 Feb 2018 up to and including 1 Mar 2018
  • 3 Mar 2018
  • 6 Mar 2018
  • 19 Mar 2018
  • 23 Apr 2018 up to and including 26 Apr 2018
  • 28 Apr 2018
  • 1 May 2018
  • 14 May 2018
  • 18 Jun 2018 up to and including 21 Jun 2018
  • 23 Jun 2018
  • 26 Jun 2018
  • 9 Jul 2018
Group full

Group 81

€ 4.620,-

21 days stay

  • 21 Feb 2018 up to and including 27 Feb 2018
  • 18 Apr 2018 up to and including 24 Apr 2018
  • 13 Jun 2018 up to and including 19 Jun 2018

short stay

Inapplicable

kort bezoek

  • 28 Feb 2018 up to and including 3 Mar 2018
  • 5 Mar 2018
  • 8 Mar 2018
  • 21 Mar 2018
  • 25 Apr 2018 up to and including 28 Apr 2018
  • 30 Apr 2018
  • 3 May 2018
  • 16 May 2018
  • 20 Jun 2018 up to and including 23 Jun 2018
  • 25 Jun 2018
  • 28 Jun 2018
  • 11 Jul 2018
Group full

Group 82

€ 4.620,-

21 days stay

  • 27 Feb 2018 up to and including 5 Mar 2018
  • 24 Apr 2018 up to and including 30 Apr 2018
  • 19 Jun 2018 up to and including 25 Jun 2018

short stay

Inapplicable

kort bezoek

  • 6 Mar 2018 up to and including 9 Mar 2018
  • 11 Mar 2018
  • 14 Mar 2018
  • 27 Mar 2018
  • 1 May 2018 up to and including 4 May 2018
  • 6 May 2018
  • 9 May 2018
  • 22 May 2018
  • 26 Jun 2018 up to and including 29 Jun 2018
  • 1 Jul 2018
  • 4 Jul 2018
  • 17 Jul 2018
Group full

Group 83

€ 4.620,-

21 days stay

  • 1 Mar 2018 up to and including 7 Mar 2018
  • 26 Apr 2018 up to and including 2 May 2018
  • 21 Jun 2018 up to and including 27 Jun 2018

short stay

Inapplicable

kort bezoek

  • 8 Mar 2018 up to and including 11 Mar 2018
  • 13 Mar 2018
  • 16 Mar 2018
  • 29 Mar 2018
  • 3 May 2018 up to and including 6 May 2018
  • 8 May 2018
  • 11 May 2018
  • 24 May 2018
  • 28 Jun 2018 up to and including 1 Jul 2018
  • 3 Jul 2018
  • 6 Jul 2018
  • 19 Jul 2018
Group full

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