PRA-186631 (Part 2)

Autoimmune diseases

Study of a new compound that is being developed for the treatment of autoimmune diseases such as rheumatism

Particulars

  • You are a healthy male of healthy no longer fertile female between 18-55 years old.
  • Your Body Mass Index (BMI) is between 18.0 and 30 kg/m2 and your body weight is between 50 and 100kg. 
  • As a female you are only allowed to participate in this study if:
    • you are surgically sterilized before the start of the study;
    • you are postmenopausal for at least 12 months (without menstrual periods).
  • As a male you are only allowed to participate in this study if:
    • you use a condom with your female partner during the study 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 is postmenopausal for at least 12 months (without menstrual periods).
    • or you are vasectomized at least 12 months before the start of the study;
    • or you are truly abstinent during the study.
  • You do not smoke or are a occasional smoker (Max. 5 cigarettes per week). During your stay in the research facility smoking is not allowed.
  • You have not participated in any other drug study within 2 months 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 at our screening centre in Utrecht or Groningen
Calculate BMI

Compensation

You will receive a gross compensation of € 2.023,- for full participation in group 7.
You will receive a gross compensation of € 2.482,- for full participation in one of the group 8 – 11.

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 groups 8-11 the study consists of 1 period where you will stay for 18 days (17 nights) in our research facility in Groningen.

For all groups the follow-up will take place 6 days after the last study compound administration for all groups.

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 into a new medication for the treatment of autoimmune diseases such as rheumatism

The purpose of this study is to investigate how safe the study 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 study compound is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). Further, the pharmacokinetics of the study compound will be compared when it is administered as 2 different oral capsules (Group 7 only). This comparison of pharmacokinetics is called relative bioavailability. In addition, the effect of food on the absorption of the study compound in the body will be investigated (Group 7 only). Also, the effect of the study compound on certain proteins in your body will be investigated (this is called pharmacodynamics).

The study compound will be tested at various dose levels. The effects of the study compound will be compared to the effects of a placebo (not for Group 7). A placebo is a capsule that does not contain any active medicine. Whether you will receive the study compound or placebo will be determined by chance.

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

Setup and duration of the study

Before the start of the study you will visit the medical screening center in Groningen or Utrecht. During this visit you will be medically screened.

For groups 1 – 6 this study consists of one period of 5 days (4 nights), in which you will stay in our research facility in Groningen.

For group 7 this study consists of three periods of 5 days (4 nights) in which you will stay in our research facility in Groningen. The following period will start 7 days after administration of the study compound in the previous period.

For groups 8 – 11 this study consists of one period of 18 days (17 nights), in which you will stay in our research facility in Groningen.

For all groups the follow-up will take place 6 days after the last dosingGroups 1 – 6 will receive the study compound once during the study, after a period of fasting (no eating and drinking except water) of 10 hours, given as oral capsules which have to be taken with a glass of water. Following administration of the study compound, you will fast for a period of 4 hours, until the scheduled lunch.

Group 7 will receive the study compound once in each of the three periods during the study: twice as oral capsules (different formulations) after you have fasted for 10 hours, and once as oral capsules after you have received a high­fat breakfast. The order in which you will receive these treatments will be determined by chance. Groups 8-11 will receive multiple doses of the study compound during the study for a period of 14 days. The study compound will be administered once or twice a day, depending on the results of groups 1 – 7, as oral capsules which have to be taken with a glass of water.

In case of once daily administration, the study compound will be administered in the morning after you have fasted for at least 10 hours. Following administration of the study compound, you will fast for a period of 2 hours, until the scheduled breakfast.

In case of twice daily administration, the study compound will be administered in the morning after you have fasted for at least 4 hours. Following administration of the study compound, you will fast for a period of 2 hours, until the scheduled breakfast. The study compound will be administered in the evening after you have fasted for at least 4 hours.
Following administration of the study compound, you will fast for a period of 1 hour, until the scheduled dinner.

For the screening, entry into the research center and follow-up you will need to have fasted for a period of 4 hours.
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

All drugs have the potential to cause adverse events.

As the study compound will be administered to humans for the first time in this study, side effects of the study compound in humans have not been reported to date. However, the study compound has been studied extensively in the laboratory and in animals. The study compound was safe and well tolerated in animals. At very high repeated doses in 1 animal, a potential effect on the immune system was seen. You will be monitored for effects on your immune system throughout the study. Except for this finding, based on the animal research and knowledge about the mechanism of action of the study compound, no specific or pronounced side effects are expected at the moment.

As with all clinical studies, the study compound and study procedures may involve unknown risks. All drugs can have temporary and permanent side effects and can cause unforeseen side effects.
If during the study more information becomes available regarding side effects that may be related to the study compound, the responsible doctor will inform you about this.
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 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 square meters). You can only take part in the study if you do not or lightly smoke.

As a male you are only allowed to participate in this study if you use an adequate method of contraception (e.g. a condom) and your female partner uses e.g. the pill or an intrauterine device or is postmenopausal for at least one year or is surgically sterilized 6 weeks before the start of the study; or if you are surgically sterilized with a confirmed post-vasectomy semen analysis; or if you are truly abstinent during the study.

As a female you are only allowed to participate in this study if you are surgically sterilized before the start of the study or if you are postmenopausal for at least 12 months (without menstrual periods). 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 will 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.

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Sign up for one of the following study groups

Group 9c

18 days stay

  • 14 Nov 2019 up to and including 1 Dec 2019
€ 2.482,- Select

Group 9d

18 days stay

  • 27 Nov 2019 up to and including 14 Dec 2019
€ 2.482,- Select

Group 10

18 days stay

  • 9 Jan 2020 up to and including 26 Jan 2020
€ 2.482,- Select

Group 7

3× 5 days stay

  • 12 Jan 2020 up to and including 16 Jan 2020
  • 20 Jan 2020 up to and including 24 Jan 2020
  • 28 Jan 2020 up to and including 1 Feb 2020
€ 2.023,- Select

Group 11

18 days stay

  • 6 Feb 2020 up to and including 23 Feb 2020
€ 2.482,- Select
Show full groups

Group 5b

Full

5 days stay

  • 11 Nov 2019 up to and including 15 Nov 2019
€ 745,- Select

Group 8b

Full

18 days stay

  • 1 Oct 2019 up to and including 18 Oct 2019
€ 2.362,- Select

Group 9

Full

18 days stay

  • 23 Oct 2019 up to and including 9 Nov 2019
€ 2.482,- Select

Group 9a

Full

18 days stay

  • 29 Oct 2019 up to and including 15 Nov 2019
€ 2.482,- Select

Group 9b

Full

18 days stay

  • 6 Nov 2019 up to and including 23 Nov 2019
€ 2.482,- Select

Group 10a

Full

18 days stay

  • 5 Dec 2019 up to and including 22 Dec 2019
€ 2.482,- Select