PRA-170111

Hypertensive disorders of pregnancy (HDP)

Study of a new compound that is being developed for the treatment of hypertensive disorders of pregnancy (HDP)

Besonderheiten (auf Englisch)

  • You are a healthy female between 18 and 45 years.
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2
  • Non-smokers and light smokers can participate, although smoking or the use of other nicotine containing products (e.g. nicotine gum) is not allowed during your stay in the clinic.
  • As a woman you are only allowed to participate in this study if:
    • you have been surgically sterilized at least 6 months before the start of the study;
    • or you use an intrauterine device or hormonal contraceptive (e.g. the pill) and you are willing to use this contraceptive until 3 months after the follow-up visit;
    • or you practice abstinent (not sexually active) as a lifestyle;
    • or your male partner has been sterilized at least 6 months before the start of the study.
  • You have not received any other investigational medicinal product within 60 days prior to the first administration of the study compound.
  • To determine if you are suitable to participate in this study, you will undergo a medical screening.
BMI berechnen

Vergütung (auf Englisch)

You will receive a gross compensation of € 503,- for full participation in one of the groups from group 1 to 4. For groups 5 to 9 you will receive a gross compensation of € 851,- for full participation in one of the groups.

Travel 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.

Periode und Studie (auf Englisch)

For groups 1 to 4 the study consists of 1 period where you will stay for 3 days (2 nights) in our research center in Groningen. The follow-up appointment for groups 1 to 4 will take place 6 to 9 days after the dosing, this appointment will be planned during your stay in the clinic.

For groups 5 to 9 the study consists of 1 period where you will stay for 5 days (4 nights) in our research center in Groningen. The follow-up appointment for groups 5 to 9 will take place 6 to 9 days after the last dosing, this appointment will be planned during your stay in the clinic.

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. 

Sonstige Information (auf Englisch)

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 to healthy female volunteers. It will also be investigated how fast the study compound is eliminated from the body (this is called pharmacokinetics). In addition, the effect of the study compound on several markers in your blood 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. A placebo is a medicine without any active ingredient.

This study does not aim to improve your health, but is necessary for the further development of this compound. The study will first take place after it has been approved by the Medical Research Ethics Committee.

Setup and duration of the study

For groups 1 to 4 the study consists of 1 period where you will stay for 3 days (2 nights) in our research center. The follow-up appointment for groups 1 to 4 will take place 6 to 9 days after the dosing, this appointment will be planned during your stay in our research center. For groups 5 to 9 the study consists of 1 period where you will stay for 5 days (4 nights) in our research center. The follow-up appointment for groups 5 to 9 will take place 6 to 9 days after the last dosing, this appointment will be planned during your stay in the clinic. You can find the exact dates of each group on our website (www.praclinicaltrials.com). If the dates do change you will be notified as soon as possible.

In groups 1 to 4, the study compound will be given once as an intravenous infusion in a blood vessel of 6 hours. In groups 5 to 9, the study compound will be given twice; once as an intravenous infusion in a blood vessel of 6 hours on day 1 and once as a subcutaneous infusion (solution of the compound administered directly under the skin) of 6 hours on day 3. Each group will receive the study compound after they have fasted, approximately 4 hours after the start of dosing of the study compound you will receive a meal. Upon admission to the clinic you must have fasted for at least 4 hours. 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 drugs have the potential to cause adverse events. The study compound is being administered to humans for the first time in this study. Because of this, side effects in humans have not been reported to date. However, the study compound has been studied extensively in the laboratory and in animals. In animals, high amounts of the study compound that were administered via multiple infusions were well tolerated at the site where the infusion was given. You should be aware that still unknown adverse 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

You are a healthy female between 18 and 45 years old. Your Body Mass Index (BMI) is between 18.5 and 29.9 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 or are a light smoker.

You are only allowed to participate in this study if you or your male partner are sterilized at least 6 months before the start of the study, or if you use an intrauterine device or hormonal contraceptive (e.g. the pill) and you are willing to use this contraceptive until 3 months after the follow-up visit, or if you are abstinent (not sexually active) during the study and you are willing to stay abstinent until 3 months after the follow-up visit.

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 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.

Registrieren Sie sich unverbindlich für eine der unten aufgeführten Studiengruppen

Group 7b

5 Tage Aufenthalt

  • 10 Mär 2020 bis einschl. 14 Mär 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen
Volle Studien anzeigen

Groep 1a

Voll
€ 503,- Wählen

Groep 1b

Voll
€ 503,- Wählen

Group 2a

Voll
€ 503,- Wählen

Group 2b

Voll
€ 503,- Wählen

Group 3a

Voll
€ 503,- Wählen

Group 3b

Voll
€ 503,- Wählen

Group 4a

Voll
€ 503,- Wählen

Group 4b

Voll
€ 503,- Wählen

Groep 5a

Voll

5 Tage Aufenthalt

  • 6 Jan 2020 bis einschl. 10 Jan 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen

Group 5b

Voll

5 Tage Aufenthalt

  • 7 Jan 2020 bis einschl. 11 Jan 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen

Group 6a

Voll

5 Tage Aufenthalt

  • 10 Feb 2020 bis einschl. 14 Feb 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen

Group 6b

Voll

5 Tage Aufenthalt

  • 11 Feb 2020 bis einschl. 15 Feb 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen

Group 7a

Voll

5 Tage Aufenthalt

  • 9 Mär 2020 bis einschl. 13 Mär 2020

Nachuntersuchung

  • Nach Vereinbarung
€ 851,- Wählen