PRA-185011

Treatment of pain

Study of a new investigational compound that may eventually be used for the treatment of for example angina pectoris and heart failure

Particulars

  • You are between 18 and 65 years old
  • You do not smoke
  • Your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2. The BMI reflects the relation between your body weight in kilograms and your height in meters.
  • As a male you are only allowed to participate in this study if:
    • you and your female partner of childbearing potential will use a condom in combination with a hormonal contraceptive or an uterine device during the study;
    • or you are vasectomized at least 6 months before the start of the study;
    • or you are true abstinent during the study (no sexual intercourse).
  • As a female you are only allowed to participate in this study if:
    • you and your fertile male partner will use a condom in combination with a hormonal contraceptive or an uterine device during the study;
    • or your male partner is vasectomized (at least 6 months before the start of the study);
    • or you are true abstinent during the study (no sexual intercourse);
    • or you are surgically sterilized;
    • or you are postmenopausal for at least 1 year (no menstruation in the last year).
  • You are only allowed to participate, if you did not participate in a drug study within 60 days prior to the first drug administration in this study.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.
Calculate BMI

Compensation

You will receive a gross compensation of € 614,- for full participation in Group 1, 2, or 5 of Part 1.

You will receive a gross compensation of € 1.155,- for full participation in Group 3 of Part 1 (two periods). 

You will receive a gross compensation of € 1267,- for full participation in Group 4a or 4b of Part 1 (two periods).

You will receive a gross compensation of € 2.621,- for full participation in one of the Groups of Part 2.

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

Part 1 of the study, consists of 1 period for groups 1, 2 and 5, in which you will stay in our research facility in Groningen for 4 days (3 nights).

For group 3, 4a and 4b of Part 1, the study consists of 2 periods, in which you will stay in our research facility in Groningen for 4 days (3 nights) in each period.

Part 2 (groups B1, B2 and B3) of the study, consists of 1 period, in which you will stay in our research facility in Groningen for 17 days (16 nights).

Finally, there will be a follow-up visit for all groups of Part 1 and 2, between 7 and 14 days after you have left the clinic (for Group 3, 4a and 4b of Part 1, after the second period).

Please note: You can only participate in one group of this study. You also have to be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

The medical screening for this study will take place in the screening center in Groningen.

For more information in about researches and a complete overview of the scheduled study dates please refer to our website in English, or German.

More info

Type of study

Soon a research study will start at PRA with a new medication that may eventually be used for the treatment of for example angina pectoris and heart failure

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. The compound has not been administered to humans before. It has been previously tested in the laboratory and on animals. The compound will be tested at various dose levels.

It will also be investigated how quickly and to what extent the compound is absorbed and eliminated from the body. In addition, the effect of food on the absorption of the compound in the body will be investigated (Group 3 and 4 of Part 1 ).

Also the effects of the compound will be compared to the effects of a placebo. A placebo is a medicine without any active ingredient. It is a ‘fake’ medicine.

The study will be performed in 2 parts, Part 1 and Part 2. The remainder of this document concerns Part 1  only.

Part 1 consist of up to 7 groups of 8 volunteers each. You can participate in one of these groups.

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

Setup and duration of the study

For group 1, 2 and 5 the study consists of 1 period in which you will stay in our research facility in Groningen for 4 days (3 nights).

For group 3 and 4, the study consists of 2 periods, in which you will stay in our research facility in Groningen for 4 days (3 nights) in each period.

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.

The compound or placebo will be given as oral capsules and in different dose levels. Dose escalation will be based on the available safety and tolerability results from the preceding group. Escalation to the next higher dose will only proceed when none of the stopping criteria have been reached and if the safety and tolerability results in the preceding group are acceptable t and after a statement of no objection of the Ethics Committee.

In Group 1, 2 and 5, all volunteers will receive the study compound or placebo once without a breakfast.

 

In Group 3 and 4, all volunteers will receive the study compound once without a breakfast and once with breakfast. In the second period you will receive a high-fat breakfast with a standard composition, which must be started exactly on time and must be finished within 20 minutes. The entire breakfast must be consumed.

Blood and urine samples will be taken regularly during the study. Your heart rhythm will be monitored continuously from 2 hours before administration of the study compound until 24 hours thereafter. As long as you are connected to the device you cannot take a shower, you have to behave as relaxed as possible and have to prevent that you will sweat. As soon as you are connected, you cannot use electric devices (razor, electric toothbrush, hairdryer) anymore and you may not wear jewelry or a watch. On certain time-points you will be asked to remain in a supine position for 10 minutes without moving, talking or sleeping. During these moments you may not listen to music, watch television or use a lap top, media player or phone in the room.

To determine if you are eligible to participate in this study, you will undergo a medical screening before the start of the study.  

Risks and medical supervision

All drugs have the potential to cause adverse events.

As compound was administered to man for the first time in this study, side effects are limited to those reported in this study. To date the compound has been administered to 24 volunteers.

 In one group of this study some volunteers developed unpleasant skin flushing. Skin flushing develops as the result of a short­lasting widening of the blood vessels in the skin, 

associated with an intense burning and tingling sensation of the skin, and a feeling of warmth and reddening of the skin. Further groups in this study will receive lower dosages than the dosage at which this side effect was seen.

The compound has been studied extensively in the laboratory and in animals. At very high doses of the compound (doses much higher than planned for this study), a number of effects were seen in animals including salivation, convulsions, vomiting, loose stools, reduced activity, and various organ abnormalities. In these studies, a dose at which no adverse effects are seen was found and a fraction of that dose will be used as the starting dose in this study. Based on the animal research and knowledge about the mechanism of action of the compound, no specific side effects are anticipated.

You should be aware that still unknown adverse effects may occur during the study.You will be under strict medical supervision during the study. Before the start of 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 65 years old. Your Body Mass Index (BMI) is between 18.0 and 32.0 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. As a male volunteer, you are only allowed to participate in this study if:

  • you and your female partner of childbearing potential will use a condom in combination with a hormonal contraceptive or an uterine device during the study;
  • or you are vasectomized at least 6 months before the start of the study;
  • or you are true abstinent during the study (no sexual intercourse).

As a female volunteer, you are only allowed to participate in this study if:

  • you are surgically sterilized;
  • or you are postmenopausal for at least 1 year (no menstruation in the last year);
  • or you and your fertile male partner will use a condom in combination with a hormonal contraceptive or an uterine device during the study;
  • or you have a vasectomized male partner (at least 6 months before the start of the study);
  • or you are true abstinent during the study (no sexual intercourse).

You are only allowed to participate, if you did not participate in a drug study within 60 days prior to the first drug administration in this study.

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 five weeks before the start of the study

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Groups

Groep B2

Full

17 days stay

  • 11 jun 2019 up to and including 27 jun 2019
€ 2.164,- Select

Groep A5

Full

4 days stay

  • 12 jun 2019 up to and including 15 jun 2019
€ 614,- Select

Groep C1

Full

17 days stay

  • 9 jul 2019 up to and including 25 jul 2019
€ 2.621,- Select