PRA-19558X

Fungal infections

Study of a new investigational compound that may eventually be used for the treatment of fungal infections

Particulars

  • You are between 18 and 60 years old.
  • Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2 and you weigh at least 50kg.
    The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • You are only allowed to participate in this study if you are using sufficient contraception or have been surgically sterilized. Women who have been postmenopausal for at least one year are also allowed.
  • You are only allowed to participate, if you did not participate in a drug study within 60 days prior to the first drug administration in this study.
  • To determine if you are eligible to participate in this study, you will first undergo a medical screening at our screening center in Groningen or Utrecht
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Compensation

You will receive a gross compensation of € 3301 for full participation in Cohort 1A or Cohort 1B.

You will receive a gross compensation of € 3034 for full participation in Cohort 2B1 or group 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 round trip, irrespective of the method of transportation.

Period of stay and research

For Cohort 1A and 1B the study consists of 2 periods in which you will stay in our research center in Groningen. In period 1 you will stay in the research center for 5 days (4 nights) followed by 7 short visits. In period 2 you will stay in our research center for 15 days (14 nights).

For Cohort 2A and 2B the study consists of 2 periods in which you will stay in our research center in Groningen. In period 1 you will stay in our research facility for 5 days (4 nights) followed by 7 short visits. In period 2 you will stay in our research center for 12 days (11 nights).

Finally, there will be a follow-up visit for all groups within 6 - 8 days after you have left the research center

Please note: You can only participate in one group of this study. You also 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.

More info

Type of study

Soon a research study will start at PRA with a new medication that may eventually be used for the treatment of fungal infections.

The study will be performed in 2 cohorts, cohort 1 and cohort 2. In cohort 1, it will be investigated what the effect is of itraconazole on how quickly and to what extent the study compound is absorbed and excreted by the body (this is called pharmacokinetics). In cohort 2, it will be investigated what the effect is of rifampicin on the pharmacokinetics of the study compound. It will also be investigated how safe the new study compound is and how well it is tolerated when it is administered alone and when it is administered together with itraconazole or rifampicin.

This study will be performed in 36 healthy male and female volunteers; 18 volunteers in cohort 1 and 18 volunteers in cohort 2.

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

Setup and duration of the study

For cohort 1 the study consists of 2 periods in which you will stay in our research facility in Groningen. In period 1 you will stay in our research facility for 5 days (4 nights) followed by 7 short visits. In period 2 you will stay in our research facility for 15 days (14 nights).

You will receive the study compound twice daily on two separate days as a intravenous infusion. From day 15 till day 30 you will have to take itraconazole once daily as an oral solution. Blood and urine samples will be taken regularly during the study.

For cohort 2 the study consists of 2 periods in which you will stay in our research facility in Groningen. In period 1 you will stay in our research facility for 5 days (4 nights) followed by 7 short visits. In period 2 you will stay in our research facility for 12 days (11 nights).
You will receive the study compound twice daily on two separate days as an intravenous infusion. From day 15 till day 33 you will have to take rifampicin once daily as tablets with a glass of water. Blood and urine samples will be taken regularly during the study.

To determine if you are eligible to participate in this study, you will undergo a medical screening before the start of the study in Groningen or Utrecht. Finally, there will be a follow-up visit for all groups within 6 - 8 days after you have left the research facility. You can find the exact dates of each group on our website. If the dates do change you will be notified as soon as possible.

Risks and medical supervision

The study compound is able to bind to a fungal enzyme. By binding to this enzyme, the cell wall of the fungus will be affected, and the fungus will experience impaired growth. Itraconazole is an antifungal medication and rifampicin is an antibiotic, both are often used to investigate interactions between drugs as they influence important metabolic pathways.

The study compound has been studied extensively in the laboratory and in animals. Furthermore, the study compound has been administered to humans in 5 clinical trials. Overall the study compound was well tolerated. In these studies, the most frequently reported side effects related to the study compound were: nausea, headache, vomiting, abdominal pain, dizziness (and fainting), fatigue, somnolence, and irritation and/or pain at the site where the study compound was intravenously administered. The majority of these side effects were mild, did not require treatment, and resolved without intervention. The study compound may also have side effects that are still unknown.

Side effects of itraconazole that occur frequently (in fewer than 1 in 10 users) are: headache, stomach ache, nausea, vomiting, diarrhea, digestive problems, unpleasant taste, skin rash, fever, shortness of breath, dizziness, and cough. Side effects of rifampicin that occur very frequently (in more than 1 in 10 users) are: fever and chills.
Side effects of rifampicin that occur frequently (in fewer than 1 in 10 users) are: platelet deficiency with or without skin bleeds, headache, dizziness, nausea, vomiting, and an increase in liver function enzymes.

Rifampicin can cause discoloration (yellow, orange, red, brown) of the teeth, urine, sweat, saliva, tear fluid, and breast milk. This is harmless. However, rifampicin can permanently discolor soft contact lenses and clothing.

Conditions for participation

You are a healthy male or female between 18 and 60 years old. Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2 and you weigh at least 50 kg (the BMI reflects the relation between your body weight in kilograms and your height in meters). You can only take part in the study if you do not smoke or use any other nicotine containing products. You are only allowed to participate in this study if you are using sufficient contraception or have been surgically sterilized. Women who have been postmenopausal for at least one year are also allowed. You are only allowed to participate, if you did not participate in a drug study within 60 days prior to the first drug administration in this study.

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 (including 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 (also referred to as theine) 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.

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Sign up for one of the following study groups

Group 2a

5 days en 12 days stay

  • 14 Jan 2020 up to and including 18 Jan 2020
  • 6 Feb 2020 up to and including 17 Feb 2020

short visit

  • 20 Jan 2020
  • 22 Jan 2020
  • 24 Jan 2020
  • 26 Jan 2020
  • 28 Jan 2020
  • 29 Jan 2020
  • 2 Feb 2020
€ 3.034,- Select

Group 2b

5 days en 12 days stay

  • 21 Jan 2020 up to and including 25 Jan 2020
  • 13 Feb 2020 up to and including 24 Feb 2020

short visit

  • 27 Jan 2020
  • 29 Jan 2020
  • 31 Jan 2020
  • 2 Feb 2020
  • 4 Feb 2020
  • 5 Feb 2020
  • 9 Feb 2020
€ 3.034,- Select
Show full groups

Group 1a

Full

5 days en 15 days stay

  • 11 Nov 2019 up to and including 15 Nov 2019
  • 28 Nov 2019 up to and including 12 Dec 2019

short visit

  • 17 Nov 2019
  • 19 Nov 2019
  • 21 Nov 2019
  • 23 Nov 2019
  • 25 Nov 2019
  • 26 Nov 2019
  • 27 Nov 2019
€ 3.301,- Select

Group 1b

Full

5 days en 15 days stay

  • 18 Nov 2019 up to and including 22 Nov 2019
  • 5 Dec 2019 up to and including 19 Dec 2019

short visit

  • 24 Nov 2019
  • 26 Nov 2019
  • 28 Nov 2019
  • 30 Nov 2019
  • 2 Dec 2019
  • 3 Dec 2019
  • 4 Dec 2019
€ 3.301,- Select