Die Studie

Clinical trial of a new compound that has been developed for the treatment of bacterial infections.

  • You are a healthy male
  • You are between 35 and 64 years old
  • You do not smoke and do not use nicotine products.
  • Your body weight is at least 50 kg and your Body Mass Index (BMI) is between 18 and 32 kg/m2

Note: 

  • You cannot participate in the trial if you have participated in another clinical trial in the 30 days prior to the screening of this clinical trial (counting from the last follow-up visit of the previous study).
  • You can only participate in this study if you have not participated in another study with a radioactive (14C) labeled study compound in the past 12 months.
  • For this trial you cannot (have) receive(d) a Covid-19 vaccine within 2 months prior to the dosing of the study drug.
  • To determine if you are suitable to participate in this trial, you will undergo a medical screening. Depending on availability, this can be done in Groningen or Utrecht.

You can only participate if you meet one of the following conditions:

  • You use a condom in combination with an additional (hormonal) contraception method used by your female partner until 3 months after dosing;
  • You use a condom when your female partner is pregnant;
  • Your  female partner is sterilized (for at least 6 months) or has passed the menopause (no period for at least 12 months);
  • You are not sexually active according to your lifestyle;
  • You only have sexual contact with a man

Zeitraum

The trial consists of 1 period during which you will stay in the research facility in Groningen for at least 16 days (15 nights) and maximal 23 days (22 nights). The length of your stay depends on the amount of radioactivity that has left your body. The follow-up visit will take place 5 to 9 days after your departure from the research facility.

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.

 

Group 1  

16 days stay

 
  • 9 Aug 2022 up to and including 24 Aug 2022
 

with possible extension until

 
  • 31 Aug 2022
 

follow-up

The follow-up appointment will be scheduled between 5 till 9 days after you leave the research center.

 

Aufwandsentschädigung

You will receive a gross compensation of €4021 for participation in this study.

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.