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NO0009-1022-GRQ

Cardiometabolic diseases

  • M/F
  • 18 - 55 years old
  • Healthy

Clinical trial of a new compound that is being developed for treatment of cardiometabolic diseases

  • From November 2025
  • 13 days
  • 1 visits

€3253,-

Well-organised and good atmosphere

Tjibbe

Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 55 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18.5 and 29.9 kg/m2

Good to know about this trial

  • The study consists of 3 parts: part A, part B and part C. You can only participate in one part
  • As a man, no contraceptive measures are required
  • The medication is given as a capsule

Download the complete research overview of part A

Download the complete research overview of part B

Download the complete research overview of part C

Wie funktioniert es

Wie funktioniert es?

Weiter lesen

Study groups

Register without obligation for the group of your preference

The research physician about this research

Additional information

  • The new compound may be used for the treatment of cardiometabolic diseases. Cardiovascular and metabolic diseases are conditions that generally never go away completely. These diseases disrupt healthy blood circulation and the way your body converts nutrients such as fats and sugars into energy.
  • The trial consists of 3 parts: part A, part B and part C. You can only participate in one part.
  • In part A, the compound is given to you once and will have to be swallowed.
  • In part B, the compound is given to you multiple times and will have to be swallowed.
  • In part C, the compound is given to you once after not eating and drinking for a night, and once following a high-fat breakfast. Both times the compound will have to be swallowed.
  • In part A and B, the safety and tolerability of the new compound will be investigated, in addition to how the compound works in the body and what the body does to the compound. In part C the effect of food on how the compound is processed by the body will be investigated.

All (possible) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. The compound has already been extensively tested in the laboratory and on animals. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects based on these animal tests. This information will also be discussed with you at the start of the medical screening. You can then ask questions to the screening physician or nurse. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.

Who can participate?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 55 years old.
  • Your weight is at least 50 kg and your Body Mass Index (BMI) is at least 18.5 and at most 29.9 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial, with a maximum of 1 cigarette per day. During your stay in our research facility, you are not allowed to smoke.
  • As a female you can only participate if you meet one of the following conditions:
    • You have passed the menopause (no periods for at least 12 months);
    • You have been sterilized.
  • As a male no contraception measures are needed.

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 of the previous 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.

WHAT IS THE COMPENSATION FOR THIS RESEARCH?

Compensation

For participation in part A or part C of the trial, you will receive a gross compensation of €1692.
For participation in part B of the trial, you will receive a gross compensation of €3253.

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 net per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

HOW LONG DOES THIS RESEARCH TAKE?

Period of stay and research

Part A: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 6 days (5 nights). The follow-up visit will take place 2 to 3 days after your departure from the research facility.
Part B: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 13 days (12 nights). The follow-up visit will take place 2 to 3 days after your departure from the research facility.
Part C: The trial consists of 2 periods during both of which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 3 days (2 nights). The follow-up visit will take place 3 to 6 days after your last departure from the research facility.

Note: You must be available for all dates to be able to participate in this clinical trial. The current dates of the clinical trial will be published on our website.

More information about the study

More information

Soon a clinical trial will start at ICON with a new compound that may be used for the treatment of cardiometabolic diseases. Cardiometabolic diseases are a group of chronic diseases that can affect the cardiovascular system (heart and blood vessels) and the metabolic health (such as blood sugar, fat and energy balance in the body).

In this trial, we investigate how safe the new compound is and how well it is tolerated when it is administered to healthy participants. Furthermore, we investigate how the compound works in the body and what the body does to the compound. The trial consists of 3 parts, Part A, Part B and Part C. In Part A and Part B, we compare the effects of the compound with the effects of a placebo. A placebo is a compound without any active ingredient. In Part C we will look at the effect of food on the uptake of the study compound.

The compound has not been used by humans before. It has been extensively tested in the laboratory and on animals.

This trial is not intended to improve your health but is necessary for the further development of this compound. The trial will only take place after it has been approved by the Independent Ethics Committee (METC) and the
Central Committee on Research Involving Human Subjects (CCMO).

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