• The study compound is a new compound that could potentially be used in the treatment of certain eye conditions. These conditions damage the macula. This is the part of the eye responsible for sharp central vision. One of these eye conditions is associated with aging, and another one with diabetes (sugar diabetes). Both are characterized by unusual leakage of blood vessels and inflammation in the eye. The study compound is being developed to block a specific protein involved in these processes. This might help prevent or reduce swelling in the macula.
• The study compound has been administered to healthy participants before.
• The study compound will be taken once by mouth as a drink. In addition, you will be administered a solution of the study compound directly into a blood vessel via an intravenous infusion. This will take approximately 15 minutes.
• This is a clinical trial with a radioactive (14C) labeled compound. Radioactively labeling a compound is done to be able to study how quickly and to what extent the compound is absorbed, converted and excreted by the body. The radioactivity disappears from the body at the same time as the compound through the feces, urine and/or breath. The compound has a negligible radiation burden which is less than from the natural background radiation that you are exposed to in the Netherlands in 1 month. This background radiation is released from space, soil, air, water, food and construction materials. To measure radioactivity levels in your body, blood, urine and feces will be collected during the trial.

You will receive a gross compensation of € 3.421,- for participation in this study. For each 24-hour visit that is needed you will receive an additional compensation of € 278,-.  

Travel expenses will be reimbursed based on the distance traveled (€ 0.23 per kilometer) with a minimum of € 14.23 and a maximum of € 193.20 (840 kilometers) per round trip, regardless of the mode of transportation.

Previously tested:

The compound has already been tested in healthy participants. In these clinical trials , the compound has been well tolerated, the following side-effects were observed most often: headache and nausea. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. There is always the risk of developing side effects which are not currently known. This information will also be discussed with you at the start of the medical screening. You can then ask the screening physician or nurse any questions you may have. Once everything is clear to you, you can decide whether to give written consent to participate in the trial. The medical screening will only take place after you have given written consent to participate in the trial. We want to emphasize that even after giving written consent, participation in any clinical trial is voluntary. You can decide at any time not to participate or to stop the medical screening or the trial. You do not need to provide a reason for why you no longer wish to participate.