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PRA-22110X

Bone diseases

  • M/F
  • 22 - 65 years old
  • Healthy

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

It was an excellent experience.

Finn

Participant ICON

Find out if you qualify for this trial

  • You are a healthy male or female
  • You are between 22 and 65 years old
  • You weigh between 50 and 110 kg
  • Your Body Mass Index (BMI) is between 18 and 30 kg/m2

Good to know about this trial

  • In part 1 of the study, the study compound is administered once.
  • As a smoker you can also participate in this medical trial.
  • You will contribute to developing medications for those with bone diseases, particularly in treating fractures.

How does it work

How does it work?

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Study groups

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The research physician about this research

Additional information

In this trial, it is examined how safe the new compound is and how well it is tolerated if it is used by healthy participants. It is also being investigated how quickly and to what extent the new compound is absorbed and excreted by the body. The compound will be tested in different strengths. The trial consists of two sequential parts: part A and part B. You can only participate in either Part A or Part B.

In part B, a DEXA scan will be done during the screening and the follow-up. This will be performed during a separate visit. This test is used to measure your bone density. You will be asked to lie on a table called a DEXA scanner. An electronic arm will pass over your body and uses a low dose of X-rays to collect this information. A scan takes 10 to 20 minutes and is safe and noninvasive.

Für Deutschland: Bitte beachten Sie: Die Arzneimittelstudien finden im niederländischen Groningen statt. Sie müssen Englisch oder Niederländisch sprechen, verstehen und lesen können, um an einer Studie teilnehmen zu können. 

Who can participate?

Target group

  • You are a healthy male or female.
  • You are between 22 and 65 years old.
  • Your weight is at least 50.0 kg and at most 110.0 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2. 
  • Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial (at most 5 cigarettes daily). During your stay in our research facility you are not allowed to smoke.

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).
  • 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. For part B, there is a second screening visit for the DEXA scan. During the phone screening phase, it will be discussed where this takes place.  

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 continuous hormonal contraception (the pill or a hormonal IUD) in combination with a condom, cervical cap, or diaphragm used by your male partner;
  • You have passed the menopause (no periods for at least 12 months);
  • You have been sterilized (ovariectomy).

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 (no periods for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You are only sexually active with a partner of the same sex.

What is the compensation for this research?

Compensation

  • You will receive a gross compensation of € 4071 for participation in one of the groups of part A.
  • For participation in one of the groups of part B of the trial, you will receive a gross compensation of € 8627.

Travel expenses will be reimbursed based on the distance traveled (€ 0.21 net per kilometer) with a minimum of € 13 and a maximum of € 176.40 (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 9 days (8 nights), followed by 8 short visits. The follow-up will be during the final short visit.

Part B: The trial consists of 4 periods in the research facility in Groningen (location van Swietenlaan 6). The first period is a stay of 12 days (11 nights). The second and third periods are both 3 days (2 nights) stays. The fourth period is a stay of 7 days (6 nights). There is 1 short visit between the second and third period and between the third and fourth period. After the fourth period, 8 short visits will follow. The follow-up will be during the final short visit. As part of the screening for this part, there is also a separate visit for a DEXA-scan. There is also a follow-up DEXA-scan at or near the final study visit.

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

Frequently asked questions

You may take part in four studies per year. There must be a period of at least 30 days between each study. A longer waiting time applies for some studies. 

Unfortunately, not all side effects of a drug can be predicted. However, doctors can estimate which side effects will occur based on previous research. During the study, the doctors and nurses carefully monitor participants. 

 

 

 

No. The amount of compensation for participating in a trial is based on the length of the trial. The longer the trial lasts and the more times you need to come back in, the higher the compensation. The compensation is provided to reimburse you for your time as a participant. The Medical Research Ethics Committee (MREC) ensures that the compensation is reasonably proportionate to the time you spend as a participant. 

 

Yes. You can download an information booklet for study subjects who participate in medical research on the website of the Dutch government here.

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