PRA-174381 Pill interaction tot € 3.094,-

Full

Description

Study of the interaction between oral contraceptives (the pill) and a new compound that is being developed for the treatment of Cystic Fibrosis

Requested participants

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

Duration and visits

  • 15 -26 days stay
  • 0 until 1 short visits afterwards

Learn more about this research?

Research details

Particulars

  • You are a non-smoker
  • Your body weight must be at more than 50kg 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.

Part A (Group A1 - A6) 18-35 years:

  • You can only participate when you are using oral contraceptives that contain ethinyl estradiol combined
    with levonorgestrel (i.e. Microgynon 20, 30 or 50, Stediril 30, Lovette, etc.) and your uterus and ovaries
    have NOT been removed.
  • When you are in doubt whether the oral contraceptive you are using contains ethinyl estradiol and
    levonorgestrel, please contact PRA.

Part B (Group B1 - B4) 18-45 year:

  • You have NOT had your uterus and/or ovaries removed.
  • You are willing to use an oral contraceptive (the pill) which will be provided by PRA during the first short
    visit.
  • 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.

 

Calculate BMI

Compensation

You will receive a gross compensation of €3094,- for participation in one of the groups of part A of the study. For your for participation in one of the groups of part B of the study you receive a gross compensation of €2343,- 

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 A the study consists of 1 period during which you will stay in our research facility in Groningen (location UMCG) for
26 days (25 nights).

For part B The study consists of 1 short visit, followed by 1 period during which you will stay in our research facility in
Groningen (location UMCG) for 15 days (14 nights). Between the short visit and your stay in the clinic, you will
take the oral contraceptive that was provided by PRA during the short visit at home.

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-174381

Type of study

The study will be performed in 2 parts: Part A and Part B.

Part A

The purpose of Part A of the study is to investigate the effect of administration of a combination treatment (a new study compound for the treatment of CF, a registered drug for the treatment of CF and a different study compound for the treatment of CF) on how quickly and to what extent the oral contraceptives ethinyl estradiol and levonorgestrel are eliminated from the body. The study will also investigate how quickly and to what extent the combination treatment compounds are eliminated from the body. It will also be investigated how safe the simultaneous administration of the combination treatment compounds, are when combined with ethinyl estradiol and levonorgestrel and how well tolerated this simultaneous administration is.

The study combination treatment is not registered as a drug but has 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 Part B of the study is to investigate the effect of administration of a combination treatment (a new study compound for the treatment of CF, a registered drug for the treatment of CF and a different study compound for the treatment of CF) on how quickly and to what extent the oral contraceptive norethindrone is eliminated from the body. The study will also investigate how quickly and to what extent the combination treatment compounds are eliminated from the body. It will also be investigated how safe the simultaneous administration of the combination treatment compounds combined with norethindrone i and how well tolerated this simultaneous administration is. The new study compound and the different study compound are not registered as a drug but have both been given to humans before. The study will only take place after it has been approved by the Independent Ethics Committee.

The study combination treatment is not registered as a drug but 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

Part A

The actual study consists of 1 period during which you will stay in the clinical research facility in Groningen (location UMCG) for 26 days (25 nights). Before the start of the study you will visit the medical screening center in Groningen.

Before you start the study, you must have been taking oral contraceptive (containing ethinyl estradiol and levonorgestrel) for approximately 1 month.  During your stay in the clinical research facility the study consists of 2 treatment periods. During the first treatment period you will take the study specific dose of the oral contraceptive (containing ethinyl estradiol and levonorgestrel) for 14 days. During the second treatment period you will continue to take the study specific dose of the oral contraceptive for 10 days, together with the combination treatment. This combination treatment consists of the new study compound given as oral tablets once daily, the registered drug given as oral tablets twice daily and the different study compound given as oral tablets once daily. Blood samples will be taken regularly during the study.

Part B

The study consists of 1 short visit, a “run-in” period (28 days where you will take the oral contraceptive norethindrone at home) followed by 1 period during which you will stay in the clinical research facility in Groningen (location UMCG) for 15 days (14 nights). Before the start of the study you will visit the medical screening center in Groningen. The norethindrone tablets will be provided during the first short visit prior to the run-in period. During the run-in period you will receive norethindrone as oral tablets once daily for 28 days. During your stay in the clinic you will also receive norethindrone as oral tablets once daily for 3 days and continue for another 10 days, together with the combination treatment. This combination treatment consists of the new study compound given as oral tablets once daily, the registered drug given as oral tablets twice daily and the different study compound given as oral tablets once daily. Blood samples will be taken regularly during the study.

Risks and medical supervision

Part A and B

The new study compound and/or the study combination treatment may eventually be used for the treatment of CF. CF is a genetic disorder that causes the body to produce unusually thick mucus. The thick mucus results in malfunction of organs like the lungs, pancreas and liver.

In the human body a certain protein that can be found in the membrane of cells plays an important role in the transport of salt and water in and out of cells. In CF, this protein does not work correctly or it is not produced sufficiently. As a result, the transport of salt and water in and out of cells is disturbed and mucus will become unusually thick. The new study compound is thought to improve the functioning of the protein by modifying the processing and trafficking of the protein.

The registered drug is approved in the United States and in some other countries for patients with certain CF abnormalities. The different study compound may also be used for the treatment of CF and also acts on the above described protein.

All drugs have the potential to cause adverse effects; the extent to which this occurs differs. In an ongoing study that is still blinded, the new study compound or placebo was administered to humans for the first time. The most common complaints that emerged following dosing were back pain, headache, and cold-like symptoms. 

To date, more than 1000 participants (272 subjects without CF and approximately 808 subjects with CF) have received at least 1 dose of the other study compound either alone or taken with the registered compound in completed or ongoing clinical studies through 01 September 2016. No significant safety risks attributable to the registered compound alone or in combination with the other study compound have been identified in these clinical studies either in healthy participants or in CF participants. Overall, the other study compound alone or in combination with the registered compound has been well tolerated.

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

Part A

You are a healthy female between 18 and 35 years old and you do not smoke. You can only participate in the study when you are using a combined oral contraceptive containing ethinyl estradiol and levonorgestrel (i.e. Microgynon 20, 30 or 50, Stediril 30, Lovette, etc.) for at least 1 month prior to the medical screening. In addition, you can only participate when you are of childbearing potential (meaning you are NOT post-menopausal and that your uterus and both ovaries have NOT been removed).

The study will be executed under standardized conditions. During the study the following are not permitted: Use of other medications, alcohol, regular coffee and tea, cola, power drinks, chocolate (including products made of chocolate), grapefruit (juice) and tobacco products. 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 four weeks before the start of the study.

Part B

You are a healthy female between 18 and 45 years old and you do not smoke. You can only participate in the study when you are not using any hormonal methods of contraception or\ when you are willing to stop taking your current oral contraceptive and take the oral contraceptive norethindrone for the duration of the study. In addition, you can only participate when you are of childbearing potential (meaning you are not post-menopausal and that your uterus and both ovaries have not been removed).
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 eight weeks before the start of the study.

More info Less info

Group A1 (18-35 years)

€ 3.094,-

26 days stay

  • 11 Sep 2017 up to and including 6 Oct 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A2 (18-35 years)

€ 3.094,-

26 days stay

  • 18 Sep 2017 up to and including 13 Oct 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A3 (18-35 years)

€ 3.094,-

26 days stay

  • 25 Sep 2017 up to and including 20 Oct 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A4 (18-35 years)

€ 3.094,-

26 days stay

  • 2 Oct 2017 up to and including 27 Oct 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A5 (18-35 years)

€ 3.094,-

26 days stay

  • 9 Oct 2017 up to and including 3 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable
Group full

Group A6 (18-35 years)

€ 3.094,-

26 days stay

  • 16 Oct 2017 up to and including 10 Nov 2017

possible prolongation

  • Inapplicable

checkups

Inapplicable

Follow-up

Inapplicable

Group B1 (18-45 years)

€ 2.343,-

15 days stay

  • 10 Oct 2017 up to and including 24 Oct 2017

possible prolongation

  • Inapplicable

checkups

  • 13 Sep 2017

Follow-up

Inapplicable
Group full

Group B2 (18-45 years)

€ 2.343,-

15 days stay

  • 17 Oct 2017 up to and including 31 Oct 2017

possible prolongation

  • Inapplicable

checkups

  • 20 Sep 2017

Follow-up

Inapplicable
Group full

Group B3 (18-45 years)

€ 2.343,-

15 days stay

  • 24 Oct 2017 up to and including 7 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 27 Sep 2017

Follow-up

Inapplicable
Group full

Group B4 (18-45 years)

€ 2.343,-

15 days stay

  • 31 Oct 2017 up to and including 14 Nov 2017

possible prolongation

  • Inapplicable

checkups

  • 4 Oct 2017

Follow-up

Inapplicable
Group full

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