Non-cystic fibrosis bronchiectasis (NCFB) is a long-term lung condition in which the airways become wider than normal. As a result, a patient may have more difficulty clearing mucus from the lungs. This leads to a build‑up of mucus in which bacteria that enter the body can easily settle and multiply. This results in a respiratory tract infection and a persistent cough. The compound brensocatib blocks a protein that is overactive in NCFB and is thought to contribute to lung inflammation. Brensocatib has already been approved and is available for the treatment of NCFB.

This trial investigates whether brensocatib influences how the body processes other medicines. To do this, a small dose of midazolam will be given. Midazolam is an approved medicine that is commonly used in the operating room to relieve anxiety and provide sedation. We will measure how much midazolam is present in the blood when it is taken alone. We will also measure the levels when it is taken together with brensocatib. This comparison helps determine whether brensocatib affects how other medicines are broken down in the body. This information is important for understanding whether brensocatib could affect the way other medicines work.

Brensocatib will be given as a tablet by mouth with water. You will receive it once daily for 13 days. Midazolam will be given as a drink by mouth with water. You will receive it twice.

Brensocatib has already been approved for the treatment of NCFB. Hence, it has already been tested in healthy individuals and patients with NCFB. In these clinical trials, the following side-effects were observed most often and are considered common, meaning they occur in around 1 – 10% of the study participants: nose and throat infection, diarrhea and vomiting, headache, problems affecting the gums, small areas of skin thickening, rash, dryness and inflammation of the skin, and hair loss. The study compound was generally safe and well tolerated. 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 screening visit, you may only consume water during the previous 4 hours. This means that, before any potential participation in the study, we will ask you to refrain from eating for a period of time. 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 € 4467 for full participation in this clinical trial.

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.