The trial

Clinical trial of a new compound that is being developed for the treatment of cancer

Who can participate?

This clinical trial investigates how the study compound behaves when administered together with other compounds. During the trial your heart rhythm can 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.

  • You are a healthy male or female
  • You are between 18 and 65 years old
  • Your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to first study compound administration in this clinical trial (counting from the follow-up visit).
  • For this trial, you cannot have received a COVID-19 vaccine within 13 days prior to the start and during this trial.
  • 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

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 sterilized or postmenopausal;
  • You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle.

Period

  • The trial consists of 2 periods during which you will stay in the research facility in Groningen for 4 days (3 nights) for both periods.
  • The (telephone) follow-up visit will take place within 4 days after your departure from the research facility in period 2

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

Group stay follow-up
2d  
  • 8 Dec 2021 up to and including 11 Dec 2021
  • 21 Dec 2021 up to and including 24 Dec 2021
 
Follow-up phone call on appointment between December 26 and 28, 2021

Compensation

  • You will receive a gross compensation of € 1638 for participation in one of the groups of this trial.

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.