A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
NCT ID: NCT06241560
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
20 participants
INTERVENTIONAL
2026-01-09
2026-08-31
Brief Summary
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Participants take one dose of BI 1015550 as a tablet. Participants then take one tablet of pirfenidone 3 times a day for one week. The dose is then increased to 2 tablets 3 times a day for the second week. In the third week the dose is increased further to 3 tablets 3 times a day. Participants then take another dose of BI 1015550 as a tablet.
Participants are in the study for a little over 1 month. During this time, they visit the study site 15 times. Two of the visits include overnight stays at the study site. The study staff also contacts the participants by phone. During the visits, the doctors collect information about participants' health and take blood samples from the participants. They compare the amount of pirfenidone and BI 1015550 in the blood. Doctors also regularly check participants' health and take note of any unwanted effects.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BI 1015550, then Pirfenidone + BI 1015550
BI 1015550
BI 1015550
Pirfenidone
Pirfenidone
Interventions
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BI 1015550
BI 1015550
Pirfenidone
Pirfenidone
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with idiopathic pulmonary fibrosis (IPF) and an indication/no contraindication for treatment with pirfenidone based on investigator's judgement.
* Body mass index (BMI) of 18.5 to 29.9 kg/m\^2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control. WOCBP taking oral contraceptives (OC) also have to use one barrier method
Exclusion Criteria
* Acute IPF exacerbation within 1 month prior to Visit 1 and/or during the screening period (investigator-determined).
* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5 x ULN or total Bilirubin \>1.5 x upper limit of normal (ULN) at Visit 1
* Patients with underlying liver cirrhosis (Child Pugh A, B or C hepatic impairment)
* Cardiovascular diseases, any of the following:
* Severe hypertension (uncontrolled under treatment ≥160/100 mmHg at multiple occasions) within 3 months of Visit 1
* Myocardial infarction, stroke or transient ischemic attack within 6 months of Visit 1
* Unstable cardiac angina within 6 months of Visit 1
* Chronic kidney disease with estimated glomerular filtration rate (eGFR) less than 90 ml/min/1.73 m\^2 at Visit 1/screening (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula or Japanese version of CKD-EPI for Japanese patients)
* Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* Relevant chronic or acute infections including but not limited to human immunodeficiency virus (HIV) and viral hepatitis
40 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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LTD The First Medical Center
Tbilisi, , Georgia
LTD "Aversi clinic"
Tbilisi, , Georgia
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Related Info
Other Identifiers
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1305-0035
Identifier Type: -
Identifier Source: org_study_id