The trial

Clinical trial of a new compound that has been developed for the treatment of cancer.

  • You are a healthy male or female.
  • You are between 18 and 65 years old. 
  • Your body weight is at least 51 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
  • You do not smoke or use other nicotine-containing products

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening in this clinical trial (counting from the follow-up visit).
  • For this trial, you cannot (have) receive(d) a COVID-19 vaccine or booster within 14 days prior to the start of 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 (no period for at least 1 year);
  • You have been sterilized (at least 6 months ago).

As a male you can only participate if you meet one of the following conditions:

  • You are using a condom in combination with an additional contraception method used by your female partner;
  • You have been sterilized or your female partner is sterilized or has passed the menopause;
  • You only have sexual intercourse with males;
  • You abstain from (hetero)sexual intercourse (you are not sexually active) according to your lifestyle

Period

  • For part 1, the trial consists of 1 period during which you will stay in the research facility in Groningen for 17 days (16 nights). The follow-up visit will take place 13 – 18 days after your departure from the research facility.
  • For part 2, the trial consists of 1 period during which you will stay in the research facility in Groningen for 15 days (14 nights). The follow-up visit will take 13 – 18 days after your departure from the research facility.

 

PLEASE NOTE: You must be available for all dates to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.

 

Group 1c  
stay  
  • 24 Aug 2022 up to and including 9 Sep 2022
 
follow up  
  • by appointment between 22 Sep 2022 up to and including 27 Sep 2022
 

 

Group 2b  
stay  
  • 10 Sep 2022 up to and including 24 Sep 2022
 
follow up  
  • by appointment between 7 Oct 2022 up to and including 12 Oct 2022
 

Compensation

  • You will receive a gross compensation of € 3140 for participation in one of the groups of part 1.
  • For participation in one of the groups of part 2 of the trial, you will receive a gross compensation of € 2882.

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, regardless of the mode of transportation.