Krebs

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

The research physician about this research

The trial is divided into three parts. You can only participate in one group of one part.


In part 2 (B) of this study the tolerability and safety after multiple doses of the study compound will be investigated.

In part 3 (C) of this study, the effect of multiple doses of the study compound in combination with an already existing compound (single dose on two different occasions in the trial) will be investigated.

Important information about this study

• Multiple start dates during the summer holidays
• Hotel accommodation possible
• The study drug has been administered to participants before
• Single oral administration of study drug as a capsule (and drink) by mouth

Who can participate?

• You are a healthy female or healthy sterilized male.
• You are between 18 and 55 years old.
• Your body weight is at least 45 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m².
• You do not smoke.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 90 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.

As a female you can only participate if you are not pregnant, not breast feeding and meet one of the following conditions:

• You are using sufficient contraception (for example the contraceptive pill or an intra-uterine device) in combination with a condom;
• You have passed the menopause (no period for at least 12 months)
• You have been sterilized or your male partner has been sterilized;
• You are not heterosexually active according to your lifestyle.
• You are only sexually active with a partner of the same sex

Compensation

• You will receive a gross compensation of € 2800 for participation in one of the groups of part 2 (B).
• You will receive a gross compensation of € 2400 for participation in one of the groups of part 3 (C).

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.

Period of stays and research

• Part 2:  The trial consists of 1 period during which you will stay in the research facility in Groningen for 10 days (9 nights), followed by 3 short visits. The follow-up visit will take place between 14 and 17 days after your departure from the research facility.
  
  
• Part 3: The effect of multiple doses of the study compound in combination with an already existing compound (single dose on two different occasions in the trial) will be investigated. The trial consists of 1 period during which you will stay in the research facility in Groningen for 10 days (9 nights), followed by 1 short visit. The follow-up visit will take place between 9 and 12 days after your departure from the research facility

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

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