Die Studie

Clinical trial of a compound that is being developed in combination with other medicinal products for the treatment of bone marrow disorders in which the body is not able to produce enough healthy blood cells.

During the trial your heart rhythm will be continuously monitored during certain moments. You will be given electrodes (small, plastic patches) on your chest and abdomen that are connected to a portable device.

Conditions for participation

  • You are are a healthy male or female
  • You are between 18 and 55 years old
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18.0 and 32.0 kg/m2.
  • Only non-smokers are allowed to participate in this clinical trial.
  • As a female you can only participate if you meet one of the following conditions:
    • You have passed the menopause (you have not had a period for at least 12 months)
    • You have been sterilized;
  • As a male you can only participate if you meet one of the following conditions:
    • You are using a condom in combination with a contraception method used by your female partner, such as a contraceptive pill or an intrauterine device.
    • You have been sterilized or your female partner is infertile (sterilized or postmenopausal);
    • You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle.
  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to this clinical trial (counting from the follow-up visit).
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be performed in Groningen or in Utrecht.

Do you have a vaccination appointment planned, or have you recently been vaccinated and do you want to know whether you can participate in this study? Feel free to contact us to discuss the possibilities.

Zeitraum

The trial consists of 1 period during which you will stay in the research facility in Groningen for 21 days (20 nights). The follow-up will take place on the day of discharge from the clinic.

Group stay
3 28 Jul 2021 up to and including 17 Aug 2021
4 4 Aug 2021 up to and including 24 Aug 2021
5 29 Sep 2021 up to and including 19 Oct 2021
6 6 Oct 2021 up to and including 26 Oct 2021

PLEASE NOTE: You must be available for all dates to be able to participate in this study. The current dates of the study will be published on our website. These are the currently planned dates; however, these may be subject to change.

Aufwandsentschädigung

You will receive a gross compensation of € 3277 for participation in one of the groups of this study. In addition travelling 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, regardless of the mode of transportation.