Study of a new compound in the treatment of inflammatory diseases

PRA-19491X

Inflammatory diseases

Particulars

  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2 at screening. 
  • You are only allowed to participate in this study if:
    • you use a condom (if you are not surgically sterilized) and your female partner uses an intrauterine device or hormonal contraception (e.g. the pill) from screening until 3 months after the study;
    • or you are fully abstinent during the study as this is your usual lifestyle.
  • You can only participate if you have not participated in another study within 3 months prior to screening. Additionally, you can only participate in group A4 if you have not participated in another study with radioactive (14C) labeled compound within 12 months prior to screening.
  • You can only participate if you have not participated in another study within 3 months prior to screening. 
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

During this part of the research, the effect of food on the research tool is examined. View part A of the study here.

Calculate BMI

Compensation

For participation in group A3 you will receive a gross compensation of €2.168,- for full participation in this group.

For participation in group A4 you will receive a gross compensation of € 1.867,- for full participation in this group. 

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 transportation.

Period of stay and research

For group A3 the study consists of 2 periods where you will stay in the research center in Groningen for 5 days (4 nights) each.

For group A4 the study consists of 1 period where you will stay in the research center in Groningen for 9 days (8 nights). 

30-40 days after the day of departure from the research center your health will be checked by telephone for the last time. This follow up call will consist of questions about your well-being and any medication that you have taken.

Please note: You have to be available for all dates of the chosen group to be able to participate in this study. The current dates are published on our website. 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 used for the treatment of inflammatory diseases.

The purpose of this study is to investigate how safe the new compound is and how well it is tolerated when it is administered to healthy volunteers. It will also be investigated how quickly and to what extent the compound is absorbed and eliminated from the body (this is called pharmacokinetics).

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

The study consists of 2 parts: Part A and Part B. The remainder of this document concerns Part A only. For Group A3, the actual study will consist of 2 periods  during which you will stay in the research center for 5 days (4 nights) each.

30-40 days after the day of departure from the research center your health will be checked by telephone for the last time. This follow up call will consist of questions about your well-being and any medication that you have taken.

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. Before the start of the study you will visit the medical screening center for a medical screening. Blood samples will be taken regularly during the study.

Risks and medical supervision

All potential drugs can cause side effects. The compound will be administered to humans for the first time in this study. However, the compound has been studied extensively in the laboratory and in animals. 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

ou are a healthy male  between 18 and 55 years old. Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2 (the BMI reflects the relationship between your body weight in kilograms and your height in meters). You can only take part in the study if you do not smoke.

If you are sexually active, you and your partner have to use a combination of 2 of the following methods of contraception, including at least one so-called ‘barrier’ method:

  • Use of hormonal contraceptives (oral, transdermal patches, vaginal or injectable) for at least 1 month prior to (the first) administration of the study compound,
  • Intrauterine device with or without hormones,
  • Condom (‘barrier’ method)

The above does not apply if you have undergone surgical sterilization (i.e., vasectomy with a post-vasectomy semen analysis negative for sperm) at least 6 months before screening. The above does also not apply to female partners who are post-menopausal (not having menstruated ≥1 year) or have undergone surgical sterilization.

The study will be executed under standardized conditions. Use of your own medication, alcohol, regular coffee and tea, cola, power drinks, chocolate (including chocolate milk), grapefruit (including 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 three weeks before the start of the study.

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Sign up for one of the following study groups

Group A4a

9 days stay

  • 16 Feb 2020 up to and including 24 Feb 2020

Telephone follow-up March 18

€ 1.867,- Select

Group A4b

9 days stay

  • 18 Feb 2020 up to and including 26 Feb 2020

Telephone follow-up March 20

€ 1.867,- Select

Group A5a

5 days stay

  • 9 Mar 2020 up to and including 13 Mar 2020

Telephone follow-up April 12

€ 1.209,- Select

Group A5b

5 days stay

  • 11 Mar 2020 up to and including 15 Mar 2020

Telephone follow-up April 14

€ 1.209,- Select
Show full groups

Group A2b

Full

5 days stay

  • 9 Jan 2020 up to and including 13 Jan 2020

Telephone follow-up February 12

€ 1.209,- Select

Group A3a

Full

2× 5 days stay

  • 28 Jan 2020 up to and including 1 Feb 2020
  • 25 Feb 2020 up to and including 29 Feb 2020

Telephone follow-up March 23

€ 2.168,- Select

Group A3b

Full

2× 5 days stay

  • 30 Jan 2020 up to and including 3 Feb 2020
  • 27 Feb 2020 up to and including 2 Mar 2020

Telephone follow-up March 25

€ 2.168,- Select