Effect of BI 1015550 on blood levels of nintedanib and pirfenidone in healthy men

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What is this study about?

The study looks at how taking several doses of a new oral medicine called BI 1015550 may affect the amount of two other medicines, the pill pirfenidone and the capsule nintedanib, that are already used for a lung condition. The purpose of the study is to see whether multiple doses of BI 1015550 change the amount of nintedanib and pirfenidone in the blood.

Healthy adult men will first receive a single dose of each of the two existing medicines, and blood samples will be taken to measure how much of each drug is in the bloodstream. After a short break, the same participants will take a series of daily doses of BI 1015550 for several days, and the same blood tests will be repeated. The study involves only routine blood draws and safety monitoring.

1 initial study visit

upon joining the study, attend the first visit where study staff provide written instructions and obtain baseline measurements.

receive information about the purpose of the trial, which is to see how bi 1015550 influences the amount of nintedanib and pirfenidone that appears in the blood.

2 first study period – single dose of nintedanib

take one ofev 100 mg soft capsule (contains nintedanib) by mouth as a single dose.

after the dose, a series of blood samples are collected over several hours to measure how much nintedanib is present in the bloodstream.

no other medication is taken during this period.

3 washout interval

allow enough time for nintedanib to be cleared from the body before starting the next period; no study medication is taken.

4 second study period – multiple doses of bi 1015550

take bi 1015550 36 mg film-coated tablet by mouth once daily for several consecutive days as instructed (multiple oral doses).

continue to attend scheduled visits for safety checks and to record any side effects.

5 single dose of pirfenidone after bi 1015550 dosing

after completing the multiple‑dose regimen of bi 1015550, take one esbriet 267 mg film-coated tablet (contains pirfenidone) as a single dose.

subsequent blood samples are taken over several hours to determine how the presence of bi 1015550 affects the amount of pirfenidone in the blood.

6 final assessment and study completion

attend a final visit where remaining safety evaluations are performed and study staff review the collected data.

the trial ends after all required samples and observations have been completed.

Who Can Join the Study?

Healthy male volunteers only, as confirmed by the study doctor after checking medical history, a physical exam, vital signs (like blood pressure BP and pulse rate PR), a 12‑lead heart test (ECG), and lab tests.
Age must be between 18 and 55 years, including both 18 and 55.
Body weight relative to height, called Body Mass Index (BMI), must be between 18.5 and 29.9 kg/m².
You must sign and date a written informed consent form that follows ICH‑GCP guidelines (International standards for good clinical practice) and local laws before joining the study.

Who Cannot Join the Study?

If any part of the medical check‑up (such as blood pressure, pulse rate or electrocardiogram (ECG)) shows results that are not normal and the doctor thinks they are important, you cannot join.
If your systolic blood pressure (the top number) is repeatedly below 90 or above 140 mmHg, or your diastolic blood pressure (the bottom number) is repeatedly below 50 or above 90 mmHg, or your pulse rate (heart beats per minute) is repeatedly below 45 or above 90, you cannot join.
If any of your lab test results (blood work, urine tests, etc.) are outside the normal range and the doctor believes they matter, you cannot join.
If you have any other ongoing disease or health problem that the doctor thinks is important, you cannot join.
Other reasons not listed here may also prevent participation.

Where you can join this trial?

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Site Name	City	Country	Status
Byysctxsqt Ifnuidzap Ptxdgl Goac &rqiz Cwm Kt	Biberach	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	09.11.2023

Trial locations

Investigated drugs:

pirfenidone is a pill taken by mouth that helps slow the buildup of scar tissue in the lungs. In this study it was given as a single dose so researchers could see how the experimental drug changes the way the body absorbs and clears pirfenidone.

nintedanib is another oral medication that works to reduce lung scarring by blocking certain enzymes involved in tissue damage. Like pirfenidone, it was administered as a single dose in the trial to measure any changes in its behavior in the body when the experimental drug is taken repeatedly.

BI 1015550 is a new, still‑investigational oral drug being tested for its effects on lung disease. In this trial participants took this medication for several days, and the researchers observed whether it altered the way the body processes pirfenidone and nintedanib.

Idiopathic pulmonary fibrosis – Idiopathic pulmonary fibrosis is a chronic lung condition where scar tissue builds up in the lungs for unknown reasons. The scarring makes the lung tissue stiff, reducing its ability to expand during breathing. Over time, the thickened tissue interferes with oxygen transfer, leading to increasing shortness of breath. The disease typically worsens gradually, with symptoms becoming more noticeable during everyday activities. Cough may also become persistent as the condition advances.

Trial ID:

2023-505522-34-00

Protocol code:

1305-0034

Trial Phase:

Human Pharmacology (Phase I) – Other

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Effect of BI 1015550 on blood levels of nintedanib and pirfenidone in healthy men

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?