PRA-170131 Cystic Fibrosis tot € 2.518,-

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 - 55 years old
  • Non-smokers only

Duration and visits

  • 21 -22 days stay

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Research details

Particulars

  • You do no smoke
  • Your Body Mass Index (BMI) is between 18.0 and 31.0 kg/m2 and your body weight is at least 51kg. The BMI shows the relation between body weight in kilograms and height in meters.
  • Males are only allowed to participate in this study if you:
    • are vasectomized at least 6 months before the start of the study;
    • use a condom and their female partner an intrauterine device;
    • use a condom and their female partner an additional hormonal contraceptive (e.g. the pill);
    • are true abstinent during the study.
  • Females are only allowed to participate in this study if:
    • your male partner has been vasectomized at least 6 months before the start of the study;
    • you are surgically sterilized or have had a tubal ligation at least 6 months before the start of the study;
    • your male partner uses a condom and you use a non-hormone releasing intrauterine device;
    • you are postmenopausal for at least 12 months (without menstrual periods);
    • you are true abstinent during the study.
  • 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 €2413,- for participation in Group A1 , A2 or A2a.  
You will receive a gross compensation of €2518,- for participation in Group B1 or B2

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 A1 , A2 and A2a, the study consists of 1 period in which you will stay in our research facility in Groningen (location UMCG) for 21 days (20 nights).

For Group B1 and B2, the study consists of 1 period in which you will stay in our research facility in Groningen (location UMCG) for 22 days (21 nights).

Information sheet PRA-170131

Type of study

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.

This study will be performed in 30 healthy male and female volunteers. The study will be performed in 2 parts, Part A and Part B. Part A will be performed in 15 healthy adult male and female volunteers.

The purpose of this study is to investigate the effect of itraconazole on how quickly and to what extent the new compound, tezacaftor and ivacaftor/D-IVA) are absorbed and eliminated from the body (this is called pharmacokinetics) when administered in triple combination.

It will also be investigated how safe the new compound is and how well it is tolerated when it is administered in triple combination with tezacaftor and ivacaftor/ (D-IVA) with and without itraconazole to healthy volunteers.

Ivacaftor is approved with the brand name Kalydeco® in the USA and the EU, for patients who have certain CF abnormalities.

Tezacaftor is a different investigational compound that may eventually be used for the treatment of CF. This compound is not registered as a drug in the EU but has been given to humans before.

Itraconazole (Part A only) is an antifungal medication registered for the treatment of fungal and yeast infections. Itraconazole is on the market since 1992.

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.

Part A: Following the screening visit, if you are eligible for participation, the study consists of 1 period in which you will stay in our research facility in Groningen (location UMCG) for 21 days (20 nights).

Part B: Following the screening visit, if you are eligible for participation, the study consists of 1 period in which you will stay in our research facility in Groningen (location UMCG) for 22 days (21 nights).

Blood samples will be taken regularly during the study.

Risks and medical supervision

During the study you will receive the new investigational compound (tablet), tezacaftor (tablets) and ivacaftor (tablets) every other day from Day 1 until Day 19. In addition you will receive itraconazole (as an oral solution) every other day from Day 11 until Day 19.

The new investigational compound may cause side effects. All drugs have the potential to cause adverse effects; the extent to which this occurs differs. The most common complaints were cough, headache, throat pain and increase in sputum. Some participants had a rash. In a study in healthy women, the risk of rash appears increased in those taking birth control pills as well as the new investigational compound in combination with tezacaftor/ ivacaftor. The rashes resolved after discontinuation of the new investigational compound in combination with tezacaftor/ ivacaftor.

The new investigational compound has been studied in animals. Adverse effects noted in some animal studies included decreased blood pressure, ulceration of the gastric mucosa (damage to the lining of the stomach) testicular injury, liver injury and muscle injury. Each of these effects was seen only at drug levels much higher (10 times or more) than expected in the current study.  

The new compound in the skin may produce damage upon exposure to light, similar to sunburn. People receiving study compound should minimize exposure to sun (such as mid-day summer sun and direct sunlight on bright days) or other UV radiation from the first dose of study compound through the follow-up phone call. To prevent damage to your skin you have to use a sunscreen which has been enough to prevent tanning in the past (at least a broad-spectrum [UV-B combination] sunscreen with an SPF [sun protection factor] of at least 15).

To date, more than 2000 participants have received at least 1 dose of ivacaftor either alone or in combination with tezacaftor. Very common side effects are headache, throat pain, upper respiratory tract infection, nasal congestion, abdominal pain, common cold, diarrhea, and rash.

For information about side effects of itraconazole you will be handed over a patient leaflet at screening.

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 55 years old. You can only take part in the study if you do not smoke.

Males are only allowed to participate in this study if you:

  • are vasectomized  at least 6 months before the start of the study;
  • use a condom and their female partner an intrauterine device;
  • use a condom and their female partner an additional hormonal contraceptive (e.g. the pill);
  • are true abstinent during the study.

Females are only allowed to participate in this study if:

  • your male partner has been vasectomized at least 6 months before the start of the study;
  • you are surgically sterilized or you have had a tubal ligation at least 6 months before the start of the study;
  • your male partner uses a condom and you use a non-hormone releasing intrauterine device;
  • you are postmenopausal for at least 12 months (without menstrual periods);
  • you are true abstinent during the study.

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), tobacco and other 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 A2a

€ 2.413,-

21 days stay

  • 28 Apr 2018 up to and including 18 May 2018

short stay

Inapplicable

Group B2

€ 2.518,-

22 days stay

  • 28 Apr 2018 up to and including 19 May 2018

short stay

Inapplicable

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