PRA-171391 Inflammatory diseases € 3.062,-

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Description

Study of an investigational compound that is being developed for the treatment of inflammatory diseases

Requested participants

  • Female, healthy, 18 - 45 years old
  • Non-smokers only

Duration and visits

  • 5 short visits afterwards
  • 14 days stay

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Research details

Particulars

  • You are a non-smoker
  • Your Body Mass Index (BMI) is between 18 and 35 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
  • You are willing to use a combination oral contraceptive (COC) containing levonorgestrel and ethinyl estradiol which will be provided by PRA
  • If you are already taking an oral contraceptive, you must be willing to stop taking it and take the oral contraceptive provided by PRA.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening visit. 
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Compensation

You will receive a gross compensation of €3.062,- 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: Pre-treatment, Treatment Period A and Treatment Period B.

Pre-treatment period
During the pre-treatment period, 3 short visits will be scheduled in our research facility in Groningen (location Martini) that you are required to attend. After these visits, you will take the COC (provided by PRA during the short visits) at home once daily for 21 days, followed by a COC-free period of 7 days. After this period, you will return to the research center before the next cycle. (Again you will take the COC at home once daily for 21 days, followed by a COC-free period of 7 days).

Treatment period A and B
The following 2 periods (Treatment Period A and Treatment Period B) you will be required to stay in our research facility in Groningen (location UMCG) for 7 days (6 nights). During Treatment Period A you will receive the COC. During Treatment Period B you will receive the new investigational compound combined with an oral contraceptive (the pill). Each period will be 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-171391

Type of study

Soon, a research study will start at PRA with an investigational compound that is being developed for the treatment of inflammatory diseases. This study will be performed in 32 healthy female subjects.

The purpose of this study is to investigate how the uptake and elimination from the body of a combination oral contraceptive (COC; 100 µg levonorgestrel and 20 µg ethinyl estradiol) is affected by the new investigational compound when it is administered together. It will also be investigated how safe the COC is when it is administered together with the new compound. The new compound has been administered to approximately 385 humans, both to healthy volunteers and to patients with inflammatory diseases.

The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

To determine if you are suitable to participate in this study, you will undergo a medical screening visit at the centre in Groningen location Martini.

Following the screening visit, if you are eligible for participation the study consist of 3 periods as follows:
 

Period

Treatment

Pre-treatment Period

21 days COC followed by 7 COC-free days

21 days COC followed by 7 COC-free days

Treatment Period A (TPA)

21 days COC followed by 7 COC-free days

Treatment Period B (TPB)

21 days COC followed by 7 COC-free days and

200 mg AQX‑1125 daily from Day 13 to Day 21

 

During the Pre-TreatmentPeriod, 3 short visits will be scheduled in our research facility in Groningen (location Martini) that you are required to attend. After each of the first 2 short visit, you will take the COC (provided by PRA during the short visits) at home once daily for 21 days, followed by a COC-free period of 7 days. The third short visit will be on the last day of the Pre-Treatment Period.

During the 2 treatment periods (Treatment Period A and Treatment Period B) you will be required to stay in our research facility in Groningen (location UMCG) for 7 days (6 nights). During Treatment Period A you will receive the COC. During Treatment Period B you will receive the new investigational compound combined with an oral contraceptive (the pill) for 9 of those days. Each period will be followed by 1 short visit.

Blood samples and urine will be taken regularly during the study.

Risks and medical supervision

The new investigational compound may cause side effects. The most frequently observed side effects of the new investigational compound in healthy volunteers and patients were: diarrhea, nausea, dyspepsia (indigestion), abdominal pain and lower abdominal pain.

The new investigational compound may also have side effects that are still unknown. The COC may also cause side effects. The most important ones are: altered mood, depressed mood, headache, nausea, abdominal pain, breast pain, breast tenderness and increased weight.

You should be aware theadverse events mentioned above and possibly other, still unknown adverse events, may occur during the study. You will be under strict medical supervision during the study.

Conditions for participation

You are a healthy female between 18 and 45 years old. You can only take part in the study if you do not smoke. You are willing to use a combination oral contraceptive (the pill) containing levonorgestrel and ethinyl estradiol which will be provided by PRA. If you are already taking an oral contraceptive, you must be willing to stop taking it and take the combination oral contraceptive provided by PRA.

The study will be done 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.

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Group 1

€ 3.062,-

14 days stay

  • 2 Feb 2018 up to and including 8 Feb 2018
  • 2 Mar 2018 up to and including 8 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 22 Nov 2017
  • 20 Dec 2017
  • 17 Jan 2018
  • 14 Feb 2018
  • 14 Mar 2018

Follow-up

Inapplicable
Group full

Group 2

€ 3.062,-

14 days stay

  • 4 Feb 2018 up to and including 10 Feb 2018
  • 4 Mar 2018 up to and including 10 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 24 Nov 2017
  • 22 Dec 2017
  • 19 Jan 2018
  • 16 Feb 2018
  • 16 Mar 2018

Follow-up

Inapplicable
Group full

Group 3

€ 3.062,-

14 days stay

  • 9 Feb 2018 up to and including 15 Feb 2018
  • 9 Mar 2018 up to and including 15 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 29 Nov 2017
  • 27 Dec 2017
  • 24 Jan 2018
  • 21 Feb 2018
  • 21 Mar 2018

Follow-up

Inapplicable
Group full

Group 4

€ 3.062,-

14 days stay

  • 11 Feb 2018 up to and including 17 Feb 2018
  • 11 Mar 2018 up to and including 17 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 1 Dec 2017
  • 29 Dec 2017
  • 26 Jan 2018
  • 23 Feb 2018
  • 23 Mar 2018

Follow-up

Inapplicable

Group 5

€ 3.062,-

14 days stay

  • 16 Feb 2018 up to and including 22 Feb 2018
  • 16 Mar 2018 up to and including 22 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 6 Dec 2017
  • 3 Jan 2018
  • 31 Jan 2018
  • 28 Feb 2018
  • 28 Mar 2018

Follow-up

Inapplicable

Group 6

€ 3.062,-

14 days stay

  • 18 Feb 2018 up to and including 24 Feb 2018
  • 18 Mar 2018 up to and including 24 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 8 Dec 2017
  • 5 Jan 2018
  • 2 Feb 2018
  • 2 Mar 2018
  • 30 Mar 2018

Follow-up

Inapplicable

Group 7

€ 3.062,-

14 days stay

  • 23 Feb 2018 up to and including 1 Mar 2018
  • 23 Mar 2018 up to and including 29 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 13 Dec 2017
  • 10 Jan 2018
  • 7 Feb 2018
  • 7 Mar 2018
  • 4 Apr 2018

Follow-up

Inapplicable

Group 8

€ 3.062,-

14 days stay

  • 25 Feb 2018 up to and including 3 Mar 2018
  • 25 Mar 2018 up to and including 31 Mar 2018

possible prolongation

  • Inapplicable
  • Inapplicable

checkups

  • 15 Dec 2017
  • 12 Jan 2018
  • 9 Feb 2018
  • 9 Mar 2018
  • 6 Apr 2018

Follow-up

Inapplicable

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