NCT06241560
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
Completed
PHASE2Ages 40+InterventionalTreatmentBoehringer Ingelheim
~20 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BI 1015550Pirfenidone
At a glance
Recruiting sites
0 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)
Measured over Up to day 34
+1 more outcome measured
Conditions
NCT06241560
Where you'd take part
This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
LTD "Aversi clinic"
Tbilisi, Georgiano site contact published
LTD The First Medical Center
Tbilisi, Georgiano site contact published
Renovatio Clinical-The Woodlands-69551
The Woodlands, Texasno site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
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Eligibility criteria
Inclusion
Male or female patients aged ≥40 years old at the time of signed consent
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
Patients with a significant disease or condition other than IPF, which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient's ability to participate in the study
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 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
What this trial measures
- Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)Up to day 34
- Maximum measured concentration of nerandomilast in plasma (Cmax)Up to day 34