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Cancer and Leukemia

Ort der Studie

Study of an investigational compound that is being developed for the treatment of tumors, lymphoma and leukemia.

 

Besonderheiten (auf Englisch)

  • For this study we are looking for healthy males and females between 18 and 65 years old who do not smoke
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2. The BMI shows the relation between body weight in kilograms and height in meters.
  • This is a study with 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 can only participate in this study if you have not participated in a drug study within 30 days prior to the first drug administration in this study and if you have not participated in a study with a radioactive (14C) labeled compound in the past 12 months.
  • As a male you are only allowed to participate in this study if you meet one of the following conditions:
    - you were vasectomized at least 6 months before the start of the study; -
    - or you use a condom and your female partner uses a hormonal contraceptive or a copper intrauterine device
    - or you are fully abstinent (not sexually active) during the study in accordance with your lifestyle
    - or you are only sexually active with a male partner.
    The above does not apply if female partners are post-menopausal (not having menstruated ≥1 year) or have undergone surgical sterilization.
  • As a female you are only allowed to participate in this study if you meet one of the following conditions:\
    - you have been postmenopausal and you have not menstruated for a period of 12 months before screening
    - you have been sterilized.
  • ​​​​​​​To determine if you are eligible to participate in this study, you will undergo a medical screening within 3 weeks before the start of the clinical trial. Based on availability this can be done in Utrecht or Groningen.

 

Vergütung (auf Englisch)

You will receive a gross compensation of €2.888,- for full participation of one of these groups, regardless the day of discharge.

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 2 periods. For the first period you will stay in our research facility in Groningen for 6 days (5 nights). For the second period you will stay in our research facility for a minimum of 6 days (5 nights) and for a maximum of 11 days (10 nights). The day of discharge depends on the levels of radioactivity measured in your blood, urine and feces. In addition a follow-up visit will take place between two and four days after the discharge of the clinic of period 2.

Please note: These are the currently planned dates; however, these may be subject to change. You have to be available for both periods.

 

Group 1

6 days en 11 days stay

12 Oct 2020 up to and including 17 Oct 2020

22 Oct 2020 up to and including 1 Nov 2020

note

Nakeuring op afspraak tussen 02 – 06 november 2020

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