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Respiratory tract infection

Ort der Studie

Study of a new compound that is being developed for the treatment of infection with RS-virus (respiratory tract infection)

 

Besonderheiten (auf Englisch)

  • Your weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 29.9 kg/m2.
  • Only non-smokers can participate in this study.
  • You have not participated in any other drug study within 30 days preceding the first administration of the study compound (counting from the last administration). Depending on the study compound in your previous study, this could be 3 or 6 months. You can call us to get more information about this.
  • As a male, you must wear a condom if you engage in any activity that allows the passage of ejaculate to another person. You are only allowed to participate if:   
    • You use a condom and your female partner uses a highly effective method of contraception;
    • or you use a condom and you have been vasectomized at least 6 months before the start of the study;
    • or you use a condom and your female partner is postmenopausal (at least 12 months without menstruation) or surgically sterilized (at least 6 months);
    • you use a condom and you are only sexually active with a male;
    • or you are fully abstinent (not sexually active) in accordance with your lifestyle.
  • As a female you are only allowed to participate in this study if:
    • you have been postmenopausal (at least 12 months without menstruation);
    • or you were surgically sterilized at least 6 months before the start of the study.
  • To determine if you are eligible to participate in this study, you will undergo a medical screening.

 

Vergütung (auf Englisch)

You will receive a gross compensation of € 4050 for full participation (3 periods) in one of the groups. If participation in period 3 is not necessary, you will receive a gross compensation of € 3285 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.

 

Periode und Studie (auf Englisch)

The study consists of a minimum of 2 and a maximum of 3 periods. In period 1 you will stay for 7 days (6 nights) and in period 2 for 11 days (10 nights) in our research facility in Groningen. Periods 1 and 2 are cross-over periods, and depending on your group, you will start with either period 1 (7 days) or period 2 (11 days). On day 1 of the first period at the latest, it will be determined whether you start with 7 or 11 days. This will be determined by drawing lots. Depending on the results of period 1 and 2, it will be decided if participation in period 3 is needed, which consists of 7 days (6 nights) in our research facility. 

Please note: You need to be available for all dates of your group, and also for period 3. If the dates change you will be notified as soon as possible.

 

Group 3

2× 7 days en 11 days stay

16 Aug 2020 up to and including 26 Aug 2020

30 Aug 2020 up to and including 5 Sep 2020

30 Sep 2020 up to and including 6 Oct 2020

note

You must also be available for group 3. No later than the second day of the study, it will be determined whether you will participate in group 3 or 4. Depending on the study results, the last period may not be necessary.

Group 4

2× 7 days en 11 days stay

16 Aug 2020 up to and including 22 Aug 2020

26 Aug 2020 up to and including 5 Sep 2020

30 Sep 2020 up to and including 6 Oct 2020

note

You must also be available for group 3. No later than the second day of the study, it will be determined whether you will participate in group 3 or 4. Depending on the study results, the last period may not be necessary.

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