Study of a new compound in the treatment of inflammatory diseases

PRA-19491X Part A

Inflammatory diseases

Particulars

  • You are a healthy male.
  • You are between 18 and 55 years old.
  • 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. 
  • To determine if you are eligible to participate in this study, you will undergo a medical screening our screening centre in Groningen.
Calculate BMI

Compensation

For participation in group A1, A2, A5 and A6 you will receive a gross compensation of € 1.209,-.

Your travel costs and two thirds of your reimbursement will be paid out as soon as possible after departure from the research center. The last part of your reimbursement will be paid out after the telephone follow up.

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 the groups A1, A2, A5 and A6 the study consists of 1 period where you will stay in the research center in Groningen for 5 days (4 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. 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 Groups A1, A2, A5 and A6, the actual study will consist of 1 period during which you will stay in the research center for 5 days (4 nights). 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. For Group A4, the actual study will consist of 1 period during which you will stay in the research center for 9 days (8 nights).

The compound or placebo will be given once in the morning as oral capsule(s) with water. In Group A4, the compound (or placebo) and the radioactive (14C)labeled compound (or placebo) will be given at the same time.

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.

In Group A4 of his study we will use radioactive markers. The additional radiation you will be exposed to in this study is negligible (that is, it is less than the natural background radiation during 1 month).

Conditions for participation

You 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.

Download PDF

Sign up for one of the following study groups

Group A2a

5 days stay

  • 7 Jan 2020 up to and including 11 Jan 2020

Telephone follow-up February 10, 2020

€ 1.209,- Select

Group A2b

5 days stay

  • 9 Jan 2020 up to and including 13 Jan 2020

Telephone follow-up February 12, 2020

€ 1.209,- Select
Show full groups

Group A1a

Full

5 days stay

  • 24 Nov 2019 up to and including 28 Nov 2019
€ 745,- Select

Group A1b

Full

5 days stay

  • 26 Nov 2019 up to and including 30 Nov 2019
€ 745,- Select

Group A1c

Full

5 days stay

  • 8 Dec 2019 up to and including 12 Dec 2019

Telephone follow up January 11

€ 1.209,- Select

Group A1d

Full

5 days stay

  • 17 Dec 2019 up to and including 21 Dec 2019

Telephone follow up January 20

€ 1.209,- Select