PRA-167611 Cystic Fibrosis € 3.232,-

Full

Description

Study of an investigational compound that is being developed to improve pulmonary function in patients with cystic fibrosis

Requested participants

  • M/F, healthy, 18 - 70 years old
  • Non-smokers only

Duration and visits

  • 32 days stay
  • 1 short visits

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Research details

Particulars

  • You do not smoke
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2 and your body weight is between 55 and 105 kg. The BMI shows the relation between body weight in kilograms and height in meters.
  • You are only allowed to participate in this study if they have been postmenopausal for at least one year or have been surgically sterilized (defined as, hysterectomy or bilateral salpingectomy or bilateral oophorectomy).

If you are sexually active, you have to use a combination of 2 of the following methods of contraception:

  • Vasectomy of the male partner at least 6 months before the pre-study screening,
  • Female sterilization (tubal ligation),
  • Hormonal contraceptives (for example oral hormonal contraception),
  • Intrauterine device with or without hormones,
  • Condom,
  • Diaphragm or cervical cap (‘barrier’ method).

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 €3.232,- 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 6 periods. For period 1, 2, 4 and 5, you will stay in our research facility in Groningen (location Martini) for 4 days (3 nights).

For period 3 and 6, you will stay in our research facility in Groningen (location Martini) for 8 days (7 nights).

Period 6 will be followed by one short visit to our research facility in Groningen (location Martini).

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-167611

Type of study

This study will be performed in 24 healthy male and female subjects.

The purpose of this study is to investigate how safe the new compound is when it is inhaled to healthy subjects. The new compound has not been administered to humans before, but it has been previously tested in the laboratory. It has been designed to be similar to an approved drug that has been used to successfully treat patients with cystic fibrosis since 1993.

In this two period study, the safety of the new compound will be compared to the safety of a registered product. The new compound is very similar to the approved product, but made by another company. Subjects will get either the new compound or the registered compound administered as single doses and then, after a 7-day gap, as once daily doses for 5 days.  After a 7 day interval, subjects will get whichever of the two drugs they did not get in the first period.

This study will also investigate how quickly and to what extent the new compound is absorbed into the bloodstream and eliminated from the body (this is called pharmacokinetics) in comparison to the registered compound. 

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 6 periods.

For period 1, 2, 4 and 5, you will stay in our research facility in Groningen (location Martini) for 4 days (3 nights). For period 3 and 6, you will stay in our research facility in Groningen (location Martini) for 8 days (7 nights). Period 6 will be followed by one short visit to our research facility in Groningen (location Martini). Blood samples, urine and sputum (mucus that is coughed up) will be taken regularly during the study. In addition, lung function tests will be done regularly.

Risks and medical supervision

The new compound and the registered compound will first be administered as single doses each of 2.5 mg, then after a 7-day gap as single doses of 10 mg, and then, after a 7-day gap, as once daily doses of 10 mg for 5 days.

The new investigational compound may cause side effects. As the new compound will be administered to humans for the first time in this study, side effects have not been reported to date. However, it is anticipated that you might get one or more of the same side effects that are reported with the comparable registered compound. These side effects are common (occur in 1 in 10 patients with cystic fibrosis or more): altered voice, sore throat or hoarse voice, chest pain, skin rash, inflammed eyes, inflammed nose, reduced lung function, fever or breathlessness.

You should be aware that  the adverse 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 male or female between 18 and 70 years old. You can only take part in the study if you do not smoke. If you are sexually active, you have to use a combination of 2 of the following methods of contraception:

  • Vasectomy of the male partner at least 6 months before the pre-study screening
  • Female sterilisation (tubal ligation)
  • Hormonal contraceptives (for example oral hormonal contraception)
  • Intrauterine device with or without hormones
  • Condom
  • Diaphragm or cervical cap (‘barrier’ method)

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 are 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 3

€ 3.232,-

32 days stay

  • 29 Apr 2018 up to and including 2 May 2018
  • 6 May 2018 up to and including 9 May 2018
  • 13 May 2018 up to and including 20 May 2018
  • 27 May 2018 up to and including 30 May 2018
  • 3 Jun 2018 up to and including 6 Jun 2018
  • 10 Jun 2018 up to and including 17 Jun 2018

short stay

Inapplicable

short visit

  • 22 Jun 2018
Group full

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