The study compound may potentially be used for the treatment of heart and vascular diseases and metabolic diseases. In metabolic diseases, something goes wrong with the conversion of nutrients into energy, or nutrients are not properly broken down. Heart and vascular diseases and metabolic diseases are a group of long-term diseases.
The trial consists of five parts: Part A, Part B, Part C, Part D and Part E. You can only participate in one part. This information concerns part D.
In all parts of this trial, we will investigate how quickly and to what extent the study compound is absorbed, transported, and eliminated from the body. In Part A to D, we will investigate how safe the study compound is and how well it is tolerated.
The study compound (or placebo) will be given as capsules by mouth with water. You will receive the study compound twice.
You will receive the study compound once with a breakfast and once without breakfast. The order in which this will occur will be determined by chance. In one period you will receive a high-fat breakfast with a standard composition. You must start it exactly on time and finish it within 20 minutes. The entire breakfast must be consumed.
During the screening, you will have to undergo a swallowing test. This is to determine whether you are able and willing to swallow a large number of capsules and tablets.
The compound has already been tested in healthy individuals. In these clinical trials, the following side-effects were observed most often: headache. You may also experience other, yet unknown, side effects. Prior to the medical screening, you will receive written information about the trial, which also describes the possible side effects. 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.