Study of a new compound that is being developed for the treatment of heart failure

Important work, nice benefits.

PRA-18427X

Heart failure

Particulars

  • You are healthy
  • You do not smoke.
  • You are between 18 and 55 years old.
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • Women are only allowed to participate in this study if:
    • you have been postmenopausal for at least one year and are between 45 and 55 years old
    • or you have been surgically sterilized at least 6 months ago.
  • For men applies:
    • Fertile men who are sexually active with a fertile partner should use a condom and your partner must use an effective form of birth control, for example such as the pill or an intrauterine device.
    • Sterilized men are not required to use contraception.
  • 2 or 4 months prior to the first administration of this study, you did not participate in another drug trial, this depends on the type of medicine you received in the previous study.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
Calculate BMI

Compensation

You will receive a gross compensation of € 956,- for full participation in group A5c. For group A6 you will receive a gross compensation of € 1.198,-. For all groups in part B you will receive € 2.871,- for full participation of this study.

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

Part A

For group A5c of the study consists of 1 period where you will stay for 7 days (6 nights) in our research center in Groningen. Group A6a and A6b consists of 1 period of 9 days (8 nights). The follow-up appointment will take place 12 to 16 days after the dosing, this appointment will be planned during your stay in our research center.

Part B

For groups B2b or B3 the study consists of 1 period where you will stay for 21 days (20 nights) in our research center in Groningen. The follow-up screening for group B2b and B3 will take place 25 to 29 days after the first dosing, this appointment will be planned during your stay in our research center.

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

The purpose of this study is to investigate how safe the study compound is and how well it is tolerated when it is administered as single or multiple doses to healthy volunteers. It will also be investigated how quickly and to what extent the study compound is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the study compound on the body will be investigated (this is called pharmacodynamics). The effects of the study compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.

This study does not aim to improve your health, but is necessary for the further development of the study 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 the groups A1 and A2 the study consists of 1 period where you will stay for 6 days (5 nights) in our research center in Groningen. In group A1 and A2 you will receive the study compound once as a subcutaneous injection in the abdomen.

For the groups A3, A4 and A5 the study consists of 1 period during which you will stay for 7 days (6 nights) in our research center in Groningen.

Groups A3, A4 and A5 will receive the study compound as a subcutaneous injection in the abdomen. Depending on the dose level, you will receive a maximum of 6 injections. Besides the study compound, you will receive also receive p-aminohippurate twice (on day -1 and day 1) as an intravenous infusion with a duration of 2 hours. P‑aminohippurate is a registered medicine that is given to investigate whether the study compound affects renal blood flow.

The follow-up appointment for group A1 to A5 will take place 12 to 16 days after the dosing, 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 21 days (20 nights) in our research center in Groningen.

You will receive the study compound once every day for fourteen days as a subcutaneous injection in the abdomen. Depending on the dose level, you will receive a maximum of 6 injections per dosing. Besides the study compound, you will receive p-aminohippurate three times (on day -1, day 1 and day 13) as an intravenous infusion with a duration of 2 hours. P‑aminohippurate is a registered medicine that is given to investigate whether the study compound affects renal blood flow. Also you will receive iohexol three times (on day -1, day 2 and day 12) as a short intravenous infusion. Iohexol is a registered medicine, which will be used to investigate whether the study compound affects renal function.

The follow-up screening for group B1 to B4 will take place 25 to 29 days after the first dosing, this appointment will be planned during your stay in our research center.

Please note: You have to be available at all mentioned dates of the group to participate. 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 centre.

Risks and medical supervision

All drugs have the potential to cause adverse events. The compound has not been administered to man before. Because the compound wil be administered to man for the first time in this study, side effects in man have not been reported to date. However the compound has been studied extensively in the laboratory and in animals.

You should be aware that still unknown adverse effects may occur during the study.You will be under strict medical supervision during the study.

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 relation between your body weight in kilograms and your heigth in meters). You can only take part in the study if you do not smoke. Fertile men who are sexually active with a fertile partner should use a condom and your partner must use an effective form of birth control. Sterilized men are not required to use contraception.

Women are only allowed to participate in this study if you have been postmenopausal for at least one year and are between 45 and 55 years old or you have been surgically sterilized at least 6 months ago.

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 (also mentioned 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 (part A) or four weeks (part B) before the start of the study.

Sign up for one of the following study groups

Group B2a

21 days stay

  • 18 Nov 2019 up to and including 8 Dec 2019

note

Medical screening also possible on Saturday

€ 2.871,- Select

Group A5c

7 days stay

  • 25 Nov 2019 up to and including 1 Dec 2019
€ 956,- Select

Group B2b

21 days stay

  • 8 Dec 2019 up to and including 28 Dec 2019
€ 2.871,- Select

Group A6a

9 days stay

  • 14 Dec 2019 up to and including 22 Dec 2019
€ 1.198,- Select

Group A6b

9 days stay

  • 16 Dec 2019 up to and including 24 Dec 2019
€ 1.198,- Select

Group B4

21 days stay

  • 6 Jan 2020 up to and including 26 Jan 2020
€ 2.871,- Select
Show full groups

Group A1a

Full

6 days stay

  • 8 Jul 2019 up to and including 13 Jul 2019
€ 835,- Select

Group A1b

Full

6 days stay

  • 10 Jul 2019 up to and including 15 Jul 2019
€ 835,- Select

Group A2a

Full

6 days stay

  • 22 Jul 2019 up to and including 27 Jul 2019
€ 835,- Select

Group A2b

Full

6 days stay

  • 24 Jul 2019 up to and including 29 Jul 2019
€ 835,- Select

Group A3a

Full

7 days stay

  • 4 Aug 2019 up to and including 10 Aug 2019
€ 956,- Select

Group A3b

Full

7 days stay

  • 6 Aug 2019 up to and including 12 Aug 2019
€ 956,- Select

Group A4a

Full

7 days stay

  • 18 Aug 2019 up to and including 24 Aug 2019
€ 956,- Select

Group A4b

Full

7 days stay

  • 20 Aug 2019 up to and including 26 Aug 2019
€ 956,- Select

Group B1

Full

21 days stay

  • 23 Sep 2019 up to and including 13 Oct 2019
€ 2.871,- Select

Group A5a

Full

7 days stay

  • 1 Oct 2019 up to and including 7 Oct 2019
€ 956,- Select

Group B2

Full

21 days stay

  • 21 Oct 2019 up to and including 10 Nov 2019
€ 2.871,- Select

Group A5a

Full

7 days stay

  • 2 Nov 2019 up to and including 8 Nov 2019
€ 956,- Select

Group A5b

Full

7 days stay

  • 4 Nov 2019 up to and including 10 Nov 2019
€ 956,- Select