• The study compound is a new compound that may potentially be used for the treatment of fungal infections. A fungal infection occurs when fungi on or inside the body begin to grow uncontrollably and cause tissue damage. In this study, we look whether the study compound substance affects the way certain medications work in the body.
• The study compound has already been administered to humans in 12 previous clinical trials.
• The study consists of two parts: Part 1 and 2. You can only participate in one part.
• In Part 1, you will receive the study compound for 20 days. This is administered directly into a blood vessel via an infusion, and in the form of tablets that you swallow.  The infusion administration will take 3 hours. In addition, you will receive a drug cocktail of low‑dose approved medications twice as tablets, capsules, or a drink.
• In Part 2, you will receive the study compound for 14 days. This is administered directly into a blood vessel via an infusion and in the form of tablets that you swallow. This infusion administration will also take 3 hours. In addition, on four occasions, you will receive a low dose of other approved medications as tablets to be swallowed.
• In Part 1, your heart is constantly monitored for nine days. For this, you will have patches (electrodes) placed on your chest, that are connected to a small device. At various times, you’ll need to lie still for 15 minutes without moving, talking, or sleeping. You also can’t listen to music, watch TV, or use a laptop or phone during those times. Outside of those times, however, you may do so.

In the 12 previous clinical studies, the study compound was administered to both healthy adults and adult patients. In total, 312 people received at least one dose of the study compound. It has also been extensively tested in the laboratory and on animals.

The doses that will be used in the current study have been used also in previous studies. They were found to be safe and well tolerated. Seven of the completed studies included only healthy participants, in these studies the most frequently reported side effects were headache, dizziness, nausea, vomiting, and fatigue. There were no important findings regarding heart tracings (ECG), physical examination, vital signs (blood pressure, heart rate, body temperature), or body weight. Still, 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.

At the start of the examination, you are only allowed to drink water for 4 hours. This means that we will ask you to fast for a period of time prior your participation in the study. You have not yet signed the form for participation in the trial. After the screening it will be announced whether you can participate.

You will receive a gross compensation of € 7,253 for participation in Part 1. For participation in Part 2, you will receive a gross compensation of € 6,569.

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.