Clinical trial of a new compound that has been developed for the treatment of autoimmune diseases
- You are a healthy male
- Your weight is between 50 kg and 110 kg and your Body Mass Index (BMI) is between 18.0 and 30.0 kg/m2.
- You do not smoke.
- You cannot participate in the trial if you have participated in another clinical trial within 60 days prior to this clinical trial (counting from the follow-up visit).
- 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 received a Covid-19 vaccine within 2 weeks prior to the start of the trial up to and including the follow-up visit.
- To determine if you are suitable to participate in this trial, you will undergo a medical screening in Groningen.
As a male you are only allowed to participate in this study if you meet one of the following requirements:
- You use a condom and your female partner uses (hormonal) contraception if she is of childbearing potential;
- You had a vasectomy (at least 6 months ago) and you use a condom;
- Your female partner is sterilized or postmenopausal and you use a condom;
- You are practicing true abstinence (not sexually active) in accordance with your lifestyle.
Prior to the study you will come for 1 short visit to the research facility in Groningen for the medical screening. The trial consists of 2 periods during which you will stay:
- The first period in the research facility in Groningen for minimal 9 days (8 nights) and maximal 15 days (14 nights). How long you need to stay in the research facility depends on the radioactivity results. If the needed radioactivity results are still not met after 15 days, there will be one 24-hour visit (1 overnight stay) in between the first and second period.
- In the second period you will stay for 5 days (4 nights) in the research facility in Groningen. The follow-up visit will take place on the day of your departure from the research facility.
PLEASE 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 chang
|Group 1 || |
|stay || |
- 22 Nov 2021 up to and including 6 Dec 2021
- 20 Dec 2021 up to and including 24 Dec 2021
|follow-up || |
note: You will stay at the research center at least until November 30 and at most until December 6. Depending on the results, you may also have to come back for one 24-hour visit from 11 to 12 December. Read more under 'Period'.
- You will receive a gross compensation of € 3.593,- for participation in group 1.
Travelling 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.