Cancer and Leukemia
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.
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
Nakeuring op afspraak tussen 02 – 06 november 2020