Study of a new compound that is being developed for the treatment of fungal infections
- For this study we are looking for healthy males, between 18 and 55 years old who do not smoke.
- Your body weight must be between 50 and 100 kg and your Body Mass Index (BMI) is between 18 and 30 kg/m2.
- You are only allowed to participate in this study if:
- you use a condom (regardless of whether you are surgically sterilized or not) and your female partner uses an intrauterine device or hormonal contraception (e.g. the pill) during the study;
- or you are true abstinent during the study.
- This is a study with radioactive (14C) labeled compound, which is expected to give a negligible amount of radiation burden: less than from the natural background radiation that is released from water, food, air and construction materials in one month. To measure radioactivity levels, both urine and faeces will be collected during the study.
- To determine if you are suitable to participate in this study, you will undergo a medical screening. Based on the availability this can be done in Groningen or Utrecht.
- In group B you will receive a nasoduodenal tube to collect bile samples in the duodenum. This tube will be removed maximally 12 hours after dosing.
You will receive a gross compensation of € 2,507,- for full participation in group A of this study. For every necessary 24-hour visit, you will receive a gross compensation of € 135,- per visit.
For participation in group B of the study, you will receive a gross compensation of € 1,249,-.
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 return, regardless of the mode of transportation.
Period of stay and research
For group A: The study consists of 1 period during which you will stay in our research facility in Groningen for 16 days (15 nights). Depending on the radioactivity levels, there is a possibility that you must come back for one to two 24-hours visits (1 overnight stay). The follow-up will take place on the last day of your stay or during the last 24-hour visit.
For group B: The study consists of 1 period during which you will stay in our research facility in Groningen for 6 days (5 nights). The follow-up will take place 5 days after your leave of the research facility.
Please note: You must be available for all dates for the group of choice to be able to participate in this study. These are the currently planned dates; however, these may be subject to change.
16 days stay
- 19 Aug 2019 up to and including 3 Sep 2019
- 9 Sep 2019 up to and including 10 Sep 2019
- 16 Sep 2019 up to and including 17 Sep 2019
6 days stay
- 12 Sep 2019 up to and including 17 Sep 2019
- 22 Sep 2019
6 days stay
- 19 Sep 2019 up to and including 24 Sep 2019
- 29 Sep 2019