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Chronic inflammatory diseases

Geschlecht Beides

Alter von 18 bis 50

Rauchgewohnheiten Nicht

BMI von 18 bis 30

Berechnen Sie Ihren BMI hier

Ort der Studie

 

Study of a new compound that is being developed for the treatment chronic inflammatory diseases (such as rheumatoid arthritis)

 

Besonderheiten (auf Englisch)

  • You are a healthy Caucasian male or female
  • You are between 18 and 55 years old
  • You do not smoke
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2.
  • You can only participate in this study if you have not participated in another study within 12 weeks prior to the first drug administration in this study.
  • As a male you are only allowed to participate in this study if:
    • You will use a condom and your fertile female partner uses an intrauterine device (including copper ones) or a hormonal contraceptive;
    • or you were vasectomized;
    • or your female partner is at least 12 months postmenopausal (without menstrual periods) or surgically sterilized;
    • or you are completely abstinent (not sexually active) during the study in accordance with your lifestyle;
    • or you are only sexual active with a male.
  • As a female you are only allowed to participate in this study if:
    • You have been postmenopausal and you have not menstruated for a period of 12 months before screening
    • You were surgical sterilized (both ovaries or fallopian tubes have been removed, or removal of the uterus)
  • To determine if you are eligible to participate in this study, you will undergo a medical screening in  Groningen. This will take place within 6 weeks before the clinical start.

Since the metabolism of the drug in the body can vary based on ethnicity, only Caucasian volunteers can participate. This means that you belong to or are descended from one of the original populations of Europe, the Middle East, North Africa, or the Indian subcontinent

 

Vergütung (auf Englisch)

You will receive a gross compensation of €1928 for full participation in Group 1a, 1b or 1c.

You will receive a gross compensation of €2389 for full participation in Group 2a or 2b.

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)

For Group 1a, 1b and 1c, the study consists of 1 period in which you will stay in our research facility in Groningen for 11 days (10 nights).

For Group 2a and 2b, the study consists of 1 period in which you will stay in our research facility in Groningen for 14 days (13 nights).

Approximately 12 to 16 days after the last administration of the compound, a follow-up visit will take place.

For group 2, the screening will consist out of two visits. During the first screening we will draw a DNA blood sample for two genotypes. For this study it is important that volunteers have a specific genotype for a so called breast cancer resistance protein (BCRP) which results in high BCRP activity. Therefore, at screening a blood sample will be taken, and your DNA will be tested for the specific BCRP genotype.

Furthermore, your DNA will be tested for the activity of the gene of an enzyme called N-acetyltransferase 2. This enzyme is important for metabolizing many types of drugs. If you have slow copies of the gene it means that your body is slower in metabolizing certain types of drugs. It is also possible that you have intermediate or rapid copies of this gene. Only volunteers who have the intermediate or rapid copies can participate in this study. If you can participate based on the DNA results, a second visit will follow. During this visit, you will undergo a medical screening.

Please note: These are the currently planned dates; however, these may be subject to change.

 

Group 1c

11 Tage Aufenthalt

16 Okt 2020 bis einschl. 26 Okt 2020

Nachuntersuchung

Nach Vereinbarung

Group 2a

 

14 days stay

26 Oct 2020 up to and including 8 Nov 2020

 

note

Follow-up by appointment between 17 - 21 November 2020

Group 2b

 

14 days stay

7 Nov 2020 up to and including 20 Nov 2020

 

note

Follow-up by appointment between 29 November - 03 December 2020.

Group 2c

 

14 days stay

11 Nov 2020 up to and including 24 Nov 2020

 

note

Follow-up by appointment between 03 - 07 December 2020.

Group 1e

 

11 Tage Aufenthalt

17 Nov 2020 bis einschl. 27 Nov 2020

 

Nachuntersuchung

Nach Vereinbarung

Groep 2d

 

14 days stay

8 Dec 2020 up to and including 21 Dec 2020

 
 

note

Follow-up by appointment between 30 December 2020 - 02 January 2021.

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