PRA-180321

Inflammatory diseases

Study of a new compound that is being developed for the treatment of inflammatory diseases

Particulars

  • You do not smoke

  • Your body weight must be at least 50 kg and your Body Mass Index (BMI) is between 18.5 and 30.0 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.

  • You are between 18 and 64 years old

  • As a male you are only allowed to participate in this study if you use sufficient contraception measures (a condom in combination with a female contraception method) or if you are surgically sterilized. 

  • As a female you are only allowed to participate in this study if

    • you use sufficient non-hormonal contraception used (a copper IUD);

    • do total abstinence (when this is your lifestyle);

    • you are surgically sterilized or if you are postmenopausal for at least 1 year. 

  • To determine if you are suitable to participate in this study, you will undergo a medical screening. 

Calculate BMI

Compensation

For participation in one of the groups of part C of the study, you will receive a gross compensation of €2,049.-.

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 4 parts. You can only participate in 1 of the parts in this study.
Part C consists of 1 period during which you will stay in our research facility in Groningen for 17 days (16 nights).

Finally, for all parts there will be a follow-up visit 7 to 10 days after the (last) administration.

Please note: You have to be available for all dates for the group of choice to be able to participate in this study. The actual dates will be published on our website. 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 study drug that may eventually be used for the treatment of inflammatory diseases. The purpose of the study is to investigate to what extent the study medication is safe and tolerated. It will also be investigated how quickly and to what extent the study medication is absorbed and eliminated from the body. In addition, the effect of the compound on the immune response will be investigated. Finally, the effect of specific genes on the compound will be investigated. The study drug is not registered as a drug and has not 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

The actual study will consist of 4 parts. You can only participate in one of the groups of 1 part of the study.

Part A consists of 1 period during which you will stay in the clinical research center in Groningen for 4 days (3 nights). Before and after the study you will visit the medical screening centre in Groningen. You will receive the study drug or placebo once in the form of a drink. Blood samples will be taken, and urine will be collected regularly during the study. There will also be a mandatory blood sample for DNA testing. Furthermore, your heart rhythm will be continuously monitored from 90 minutes before dosing until 24 hours after with the use of a Holter.

Part B consists of 2 periods during both you will stay in the clinical research center in Groningen for 4 days (3 nights). Before and after the study you will visit the medical screening centre in Groningen. You will receive the study drug once per period in the form of a tablet. Blood samples will be taken, and urine will be collected regularly during the study. There will also be a mandatory blood sample for DNA testing. Furthermore, your heart rhythm will be continuously monitored from 90 minutes before dosing until 24 hours after with the use of a Holter

Part C consists of 1 period during which you will stay in the clinical research center in Groningen for 17 days (16 nights). Before and after the study you will visit the medical screening centre in Groningen. You will receive the study drug once a day for 14 days in the form of a drink. Blood samples will be taken, and urine will be collected regularly during the study. There will also be a mandatory blood sample for DNA testing. Furthermore, your heart rhythm will be continuously monitored from 90 minutes before dosing until 24 hours after with the use of a Holter.

Part D consists of 3 periods during all you will stay in the clinical research center in Groningen for 4 days (3 nights). Before and after the study you will visit the medical screening centre in Groningen. You will receive the study drug once per period. Once in the form of a drink and two times in the form of a tablet. When administered as a tablet, you will once receive the compound after a high-fat breakfast. The breakfast consists of 2 fried eggs, 1 portion of bacon (or brie 60+), 1 portion of fried potatoes, 2 slices of toasted bread and 1 glass of whole milk. Blood samples will be taken, and urine will be collected regularly during the study. There will also be a mandatory blood sample for DNA testing. Furthermore, your heart rhythm will be continuously monitored from 90 minutes before dosing until 24 hours after with the use of a Holter.

You have to be available for all dates for the group of choice to be able to participate in this study.

Risks and medical supervision

As the compound will be administered to humans for the first time in this study, side effects in humans have not been reported to date. The compound has been studied extensively in the laboratory and in animals. In studies with rats and monkeys, no adverse effects on organs and on vital function, or toxic effects were seen. Furthermore, laboratory studies could not identify genotoxic effects. 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

You are a healthy male or female between 18 and 64 years old. You can only take part in the study if you do not smoke. You are only allowed to participate in this study if you use sufficient contraception measures (a condom in combination with a female contraception method) or if you are surgically sterilized or postmenopausal for women. 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 four weeks before the start of the study.

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Sign up for one of the following study groups

Group C4

17 days stay

  • 28 Nov 2019 up to and including 14 Dec 2019
€ 2.049,- Select

Group C5

17 days stay

  • 6 Jan 2020 up to and including 22 Jan 2020
€ 2.049,- Select
Show full groups

Group D2

Full

3× 4 days stay

  • 5 Sep 2019 up to and including 8 Sep 2019
  • 12 Sep 2019 up to and including 15 Sep 2019
  • 19 Sep 2019 up to and including 22 Sep 2019
€ 1.517,- Select

Group C4

Full

17 days stay

  • 26 Sep 2019 up to and including 12 Oct 2019
€ 2.049,- Select

Group C4

Full

17 days stay

  • 24 Oct 2019 up to and including 9 Nov 2019
€ 2.049,- Select