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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

4 criteria

  • 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 trial?

5 criteria

  • 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.
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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.

What is already known about the treatment

  • Esbriet (pirfenidone)

    This medication is taken by mouth as a film‑coated tablet. It is an approved drug that is widely used and described in medical literature for treating idiopathic pulmonary fibrosis, a scarring lung disease. Pirfenidone works by lowering the activity of cells that make scar tissue and by reducing inflammation in the lungs. It belongs to the class of anti‑fibrotic agents.

  • BI 1015550

    This investigational product is also taken orally as a film‑coated tablet. It is currently being studied in clinical trials and has not yet received market approval. The drug is being tested for its ability to treat pulmonary fibrosis by blocking specific enzymes that drive the growth of scar‑forming cells. It is classified as an experimental kinase inhibitor with anti‑fibrotic potential.

  • Ofev (nintedanib)

    This drug is administered by mouth in the form of a soft capsule. It is an approved treatment, well documented in the literature, for idiopathic pulmonary fibrosis and other related lung disorders. Nintedanib blocks several growth‑factor receptors, which slows down the formation of scar tissue in the lungs. It is classified as a tyrosine‑kinase inhibitor used as an anti‑fibrotic therapy.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-505522-34-00Protocol code1305-0034Estimated enrolment14 patientsSponsorBoehringer Ingelheim International GmbH

sourced from the EU Clinical Trials Register and site verification

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