This trial will be executed in healthy male participants. You can participate only once in this trial.
To check if you are eligible to participate a medical screening will take place before the start of the trial. Depending on availability, this can be performed in Groningen or Utrecht. This screening will take place within 4 weeks before the start of the clinical trial.
The clinical trial consists of 1 period during which you will stay in the research facility in Groningen (location van Swietenlaan 6) for 18 days (17 nights). After the period of stay, you will return for the follow-up. This will take place between 2 and 9 days after your discharge from the research facility.
You will receive the compound once a day on day 1 and day 15 and twice a day from day 3 through day 14. On day 2 no compound or placebo will be given. You will be given the compound or placebo as tablets taken in with a glass of water. During the first 4 hours after morning administration of the study compound you will not be allowed to lie down (except when instructed to do so by one of the investigators), as this may influence the uptake of the study compound. On Day 10 you will receive a high fat breakfast, which must be started exactly on time and must be finished within 20 minutes. The entire breakfast must be consumed. The high-fat breakfast is a large breakfast, including 2 fried eggs, fried potatoes and bacon or cheese. It can be difficult to consume the entire breakfast, for light eaters.
During the trial, blood will regularly be drawn and urine will be collected. Prior to screening, admission, and the follow-up, you have to stay fasted for 4 hours. You can only drink water prior to your visit. This means that we will ask you to fast prior to any participation in the trial. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.
Consumption of medication, alcohol, coffee and tea, cola, power drinks and chocolate (including chocolate milk), grapefruit (including juice) and tobacco / nicotine containing products are not allowed during the trial. Also, before the start of the trial and when you are not staying in the research facility, there will be restrictions for these products. Use of decaffeinated coffee and (herbal) teas without caffeine (also called theine) is allowed.