PRA-19210X

Allergic inflammation diseases

Study of a new compound that could be used for the treatment of allergic inflammation diseases such as atopic dermatitis (skin inflammation) or asthma

Particulars

  • You are healthy
  • You are between 18 and 55 years old
  • You do not smoke
  • Your bodyweight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • As a male you are only allowed to participate in this study if:
    • you use a condom and your fertile female partner uses a form of contraception (e.g. the pill);
    • or your female partner is surgically sterilized;
    • or your female partner has been postmenopausal for at least 12 months (without menstrual periods);
    • or you have been vasectomized at least 6 months before the start of the study;
    • or you are totally abstinent (not sexually active)during the study as a result of your lifestyle.
  • As a female you are only allowed to participate in this study if:
    • you have been postmenopausal for at least 12 months (without menstrual periods);
    • or if you have been surgically sterilized for at least 6 months before the start of the study;
    • or if you use an intrauterine device or hormonal contraceptives (e.g. the pill) combined with 1 of the following forms of contraception: a diaphragm or cervical cap or a condom;
    • or you are totally abstinent (not sexually active) during the study, as a result of your lifestyle;
    • or your male partner has undergone a vasectomy at least 6 months before screening.
  • You have not participated in any other drug study within 60 days preceding the first administration of the study compound.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.
Calculate BMI

Compensation

You will receive a gross compensation of € 821,- for full participation in one of the groups from group A1, A2 or A4. For group A3 you will receive a gross compensation of € 1632,- for full participation. For group B1 till B4 you will receive a gross compensation of € 1622,- for full participation in one of the groups.

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, irrespective of the method of return.

Period of stay and research

Part A

For group A1, A2 and A4 the study consists of 1 period where you will stay for 5 days (4 nights) in our research center in Groningen, followed by 2 short visits. The follow-up appointment will take place during the last short visit; this appointment will be planned during your stay in our research center.

For group A3 the study consist of 2 periods where you will stay for 5 days (4 nights) each period in our research center in Groningen, followed by 1 short visit after each period. Finally there will be a follow-up visit; this appointment will be planned during your stay in our research center.

Part B

For groups B1 to B4 the study consists of 1 period where you will stay for 11 days (10 nights) in our research center in Groningen, followed by 2 short visits. The follow-up appointment will take place during the last short visit; this appointment will be planned during your stay in our research center.

Please note: You must 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 new research study will start at PRA with a new compound that may be able to be used for the treatment of allergic inflammatory diseases such as atopic dermatitis (skin inflammation) or asthma. 

The purpose of this study is to investigate how safe the study compound is when it is administered to healthy subjects. The study compound has not been administered to humans before. It has been previously tested in the laboratory and on animals. The study compound will be tested at various dose levels.

It will also be investigated how quickly and to what extent the study compound is absorbed and eliminated from the body. The effect of food will also be examined. In addition, the effect of the study compound on the body will be investigated. The effects of the study compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient.

This study does not aim to improve your health, but is necessary for the further development of this compound. The study will only take place after it has been approved by the Independent Ethics Committee.

Setup and duration of the study

Part A

For group A1, A2 and A4 the study consists of 1 period where you will stay for 5 days (4 nights) in our research center, followed by 2 short visits. The follow-up appointment will take place during the last short visit, this appointment will be planned during your stay in our research center.

For group A3 the study consists of 2 periods where you will stay each period for 5 days (4 nights) in our research center in Groningen, followed by 1 short visit after each period. Finally there will be a follow-up visit, this appointment will be planned during your stay in our research center.

Group A1, A2 and A4 will receive the study compound once as oral capsules with (tap) water. You will receive the study compound after you fasted for at least 10 hours.

Group A3 will receive the study compound once in each period as oral capsules with (tap) water. In period 1 you will receive the study compound after fasting for 10 hours. In period 2, you will receive the study compound after a high-fat breakfast, which need to be finished in 20 minutes.

Part B

For groups  B1 to B4 the study consists of 1 period where you will stay for 11 days (10 nights) in our research center in Groningen, followed by 2 short visits. The follow-up appointment will take place during the last short visit, this appointment will be planned during your stay in our research center. The study compount will be given once daily for 7 consecutive days as oral capsules with (tap) water. Prior to the study compound being administered, you must have fasted for at least 10 hours. Based on the outcome of part A of this study, it may be decided to administer the study compound with a breakfast. Furthermore, based on the results in previous groups in part A or B, it may  be decided to administer the study compound twice daily instead of once daily. You will be informed in case any of these changes.

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. Upon admission to the clinic you must have fasted for at least 4 hours. Before the start of the study you will visit the medical screening centre for a medical screening. Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs can cause adverse events. As the study compound will be administered to humans for the first time in this study, adverse events of the study compound in humans have not been reported to date. However, the study compound has been studied extensively in the laboratory and on animals. In mice, the study compound was associated with a lower cholesterol level in the blood. In dogs, vomiting was observed at higher doses of the study compound. These symptoms disappeared after the treatment was stopped. Based on animal studies, the following potential side effects may occur: low cholesterol and vomiting.

You should be aware that still unknown side effects may occur during the study. You will be under strict medical supervision during the study and at the end of the study you will undergo an extensive medical screening.

Conditions for participation

You are a healthy male or female between 18 and 55 years old. Your body weight is at least 50 kilogram and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2 (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.

As a female volunteer you are only allowed to participate in this study if you use a medically acceptable method of contraception (for example hormonal contraceptives or an intrauterine device) or if you have been postmenopausal for at least one year or if you have been surgically sterilized or if you practice complete abstinence as a lifestyle. Women who are pregnant or breastfeeding are not eligible for participation. As a male, if you are not vasectomized, you can participate if you use a condom and your female partner uses sufficient contraception (for example hormonal contraceptives or an intrauterine device), or if you are abstinent during the study if this is your lifestyle.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (milk), grapefruit (juice) and tobacco products during the study is not allowed. Also before the study and each period there may be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called 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.

Compensation

You will receive a gross compensation of € 821,- for full participation in one of the groups of group A1, A2 or A4. For group A3 you will receive a gross compensation of € 1632,- for full participation. For groups B1 to B4 you will receive a gross compensation of € 1622,- for full participation in one of the groups.

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.

Sign up for one of the following study groups

Group B3

11 days stay

  • 19 Nov 2019 up to and including 29 Nov 2019

short visit

  • 2 Dec 2019
€ 1.622,- Select

Group B4

11 days stay

  • 14 Dec 2019 up to and including 24 Dec 2019

short visit

  • 27 Dec 2019
€ 1.622,- Select
Show full groups

Group A1a

Full

5 days stay

  • 11 Aug 2019 up to and including 15 Aug 2019

short visit

  • 18 Aug 2019
€ 821,- Select

Group A1b

Full

5 days stay

  • 13 Aug 2019 up to and including 17 Aug 2019

short visit

  • 20 Aug 2019
€ 821,- Select

Group A2

Full

5 days stay

  • 25 Aug 2019 up to and including 29 Aug 2019

short visit

  • 1 Sep 2019
€ 821,- Select

Group A3

Full

2× 5 days stay

  • 8 Sep 2019 up to and including 12 Sep 2019
  • 25 Sep 2019 up to and including 29 Sep 2019

short visit

  • 15 Sep 2019
  • 2 Oct 2019
€ 1.632,- Select

Group B1

Full

11 days stay

  • 24 Sep 2019 up to and including 4 Oct 2019

short visit

  • 7 Oct 2019
€ 1.622,- Select

Group A4

Full

5 days stay

  • 13 Oct 2019 up to and including 17 Oct 2019

short visit

  • 20 Oct 2019
€ 821,- Select

Group B2

Full

11 days stay

  • 22 Oct 2019 up to and including 1 Nov 2019

short visit

  • 4 Nov 2019
€ 1.622,- Select