Die Studie

Study of a new compound for the treatment of hereditary swelling of skin or tissue

  • You are a healthy male.
  • You are between 18 and 65 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2
  • You do not smoke. You can also participate if you have quit smoking at least 3 months before the start of the 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 condom, diaphragm or cervical cap;
  • 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;
  • or you use a condom if your partner is pregnant.

Note: 

  • This is a study with microtracer radioactive (14C) labeled compound, which is expected to give a negligible amount of radiation burden: less than from the natural background radiation that is released from water, food, air and construction materials in one month.
  • You have not participated in any other drug study within 30 days preceding the first administration of the study compound (counting from the last study drug administration). In addition, you have not participated in a study with a radioactive (14C) labeled compound in the past 12 months.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

 

Zeitraum

The study consists of 1 period where you will stay for 7 days (6 nights) in our research facility in Groningen. After you leave our research facility, no more visits are required. If the dates do change you will be notified as soon as possible.

Group 2  
stay  
  • 2 Nov 2021 up to and including 8 Nov 2021
 

Aufwandsentschädigung

You will receive a gross compensation of € 1265 for full participation. 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.