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Hereditary swelling

Ort der Studie

Study of a new compound that is being developed for the treatment of hereditary swelling (body fluid accumulation) of skin or tissue.

Particulars

  • You are a healthy male or female between 18 and 60 years old
  • You do not smoke, or quit at least 1 month before the start of the study.
  • Your weight is at least 50 kg and 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 height in meters.
  • You have not participated in any other drug study within 30 days preceding the first administration of this study compound, counting from the last day in the previous study.
  • As a male you are only allowed to participate in this study if:
    • your female partner uses a hormonal contraceptive (e.g. the pill or intrauterine device) in combination with a diaphragm, cervical cap or condom;
    • or a condom if your partner is pregnant;
    • or you were vasectomized at least 6 months before the start of the study;
    • or your female partner is postmenopausal (at least 12 months without menstruation) or surgically sterilized (at least 6 months);
    • or you are only sexually active with a male;
    • or you are completely abstinent (not sexually active) in accordance with your lifestyle;
  • As a female you are only allowed to participate in this study if:
    • or you were surgically sterilized at least 6 months before the start of the study;
    • or you have been postmenopausal for at least 12 months.
    • Women who are breastfeeding or pregnant cannot participate.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

Compensation

You will receive a gross compensation of € 1522 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 round trip, irrespective of the method of transportation.

Period of stay and research

The study consists of 1 period where you will stay for 10 days (9 nights) in our research facility in Groningen.
After this period of stay you will have to return once for your follow-up visit.
This will take place between 5 - 9 days after leaving our research centre:
Group 1: between 30 March and 3 April 2020.
Group 2: between 06 April and 10 April 2020,

Group 2

10 days stay

  • 23 Mar 2020 up to and including 1 Apr 2020

Follow-up

  • by appointment
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