Gerinnungsprobleme

Gerinnungsprobleme

Clinical trial of an existing compound that has undergone a minor change in the production process and that has been developed for the treatment of clotting problems

The research physician about this research

In this clinical trial you will receive two types of medication: a blood thinner and the study compound. Both the study compound and the blood thinner are already being used by patients. You will be directed to take the blood thinner orally at home for 9 days. During this time you will measure your blood value with a small device which will be given to you. You will report the result to one of our research staff who will tell you  how much of the blood thinner to take. Your blood values will then be checked at our research facility to determine whether you can continue with the trial. If you continue, you will receive the study compound. The study compound is an existing compound for treatment of clotting problems.

As a female, you can only participate in this study if you have passed the menopause or have been sterilized.

 
Important information about this study

• You can also participate in this study when you smoke
• This drug has already been used in 250,000 patients
• This clinical trail is partly from home

Who can participate?

• You are a healthy male
• You are between 18 and 55 years old
• Your weight is between 50 and 100 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
• Both non-smokers and light smokers or occasional smokers are allowed to participate in this clinical trial. However, smoking is not allowed during your stay in the research facility.

Note: 

• You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to this clinical trial (counting from the follow-up visit).
• For this trial, you cannot (have) receive(d) a COVID-19 vaccine within 2 weeks prior to the first dosing of the study compound and during 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 are not breast feeding and meet one of the following conditions:

• You have passed the menopause (no menstrual cycle for at least 12 months);
• You have been sterilized;

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 postmenopausal;
• You abstain from heterosexual intercourse (you are not sexually active) according to your lifestyle.

Compensation

• You will receive a gross compensation of € 2260 for participation in the entire study.
• If you do not meet the selection criteria after receiving the blood thinner, you will receive a gross compensation of  €1461.

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

The trial including the medical screening will be approximately 4 to 6 weeks long.

• • If you pass screening, you will be admitted for one night at the  research facility in Groningen. After the overnight stay, you will be directed to take a blood thinner and measure your blood values at home for 9 days. You will be asked to come to our research facility for one short visit on Day 5 or Day 6 after starting the blood thinner.

  • After 9 days you will return to our research facility and blood tests will be taken to determine whether you can continue with the trial. If you continue, you will stay in the research facility of Groningen for 5 nights (6 days). You will receive the study compound during this period. This period will be followed by 3 short visits. The last follow-up will take place during the last short visit approximately 2 weeks after the start of the period.

  • In case you do not meet the desired lab values after receiving the blood thinner, you cannot continue with the trial. This will be discussed with our research physician, you will not receive the study compound. You will be reimbursed for all the activities you have done in the study to this moment.

PLEASE NOTE: You must be available for all the dates in the study. The short visits are flexible and you can choose between two dates.