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MI7965-0002-GRQ

  • M/F
  • 18 - 59 years old
  • Healthy

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

  • From September 2026
  • 6 days
  • 2 visits

€2.495,-

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Everything was well organized and handled professionally.

Marit Deelnemer ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 18 and 59 years old
  • You weigh more than 50 kg
  • Your Body Mass Index (BMI) is between 18 and 33 kg/m2

Good to know about this trial

  • The trial consists of two parts. You can only participate in one part
  • You can participate in this trial as a fertile female, if you use the right contraception
  • Both non-smokers and light smokers are allowed to participate in this clinical trial

 

 

Everything was well organized and handled professionally.

Marit Deelnemer ICON

Wie funktioniert es

Wie funktioniert es?

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Study groups

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The research physician about the research

Additional information

  • In this trial we will investigate how safe the study compound is and how well it is tolerated when it is used by healthy participants.
  • The trial consists of two parts. You can only participate in one part.
  • In Part 1, participants will receive the study compound once. In Part 2, participants will receive the study compound once daily or twice daily for 14 days consecutively.
  • The study compound will be given as oral capsules with a glass of water.
  • You will have physical examinations, including extensive eye examinations performed by a trained eye care professional.  You will also have blood and urine tests at various times throughout the trial. These examinations and tests assess your health throughout the trial and the safety of the study compound.

Who can participate?

Target group

  • You are a healthy male or female.
  • You are at least 18 and at most 59 years old.
  • Your weight is at least 50.0 kg and your Body Mass Index (BMI) is at most 33.0 kg/m2
  • Both non-smokers and smokers are allowed to participate in this clinical trial. However, during your stay in our research facility you are not allowed to smoke.
  • The use of contact lenses is not allowed during the study. If you are usually wearing contact lenses, you have to agree to wear glasses instead.
  • 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 use hormonal contraception (for example the contraceptive pill or intra-uterine device containing hormones);
    • You use a copper intra-uterine device;
    • You have passed the menopause (no periods for at least 12 months);
    • You have been sterilized or your male partner has been sterilized;
    • You are only sexually active with a partner of the same sex;
    • You are not sexually active according to your lifestyle.
  • As a male you can only participate if you meet one of the following conditions:
    • You use a condom during sex;

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the first compound administration in this clinical trial (counting from the follow-up visit).
  • The use of contact lenses is not allowed during the trial. If you are usually wearing contact lenses, you have to agree to wear glasses instead.
  • 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

Part 1: You will receive a gross compensation of € 2.495,- for full participation. Travel expenses will be reimbursed based on the distance traveled (€ 0.23 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.

Part 2: You will receive a gross compensation of € 6.021,- for full participation. Travel expenses will be reimbursed based on the distance traveled (€ 0.23 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 1: 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), followed by 2 telephonic appointments and 2 short visits. The follow-up visit will take place during the final short visit.

Part 2: The trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 19 days (18 nights), followed by 4 short visits. The follow-up visit will take place during the final short visit.

Note: You must be available for all dates to be able to participate in this clinical trial. 

Further information about the research

Further information

All (potential) medicines can cause side effects. Because the compound has not yet been administered to humans, there are currently no known side effects in humans. The new compound has been studied extensively in the laboratory and in animals. Some side effects have been found in animal studies; these effects are dose dependent and specific criteria have been applied to minimize the likelihood of them occurring at the doses to be administered in this study. Effects observed include effects on the gastrointestinal tract (weight loss, vomiting, and at high doses blood in the stool and/or damage to tissue in the intestines) and effects on the eyes (watery or mucus-like eye discharge, and at high doses changes to the surface of the eye (cornea)or changes to the lens of the eye). Skin rash and hair loss were observed but it is not known if they were caused by the study compound. Tremors (trembling), and at very high drug concentrations, substantially higher than will be experienced in this trial, convulsions (sudden, uncontrolled muscle movements) were seen. In rare cases (<0.1%), serious side effects can occur during the first administration to humans. 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.

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