Actively Recruiting
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
Led by Boehringer Ingelheim · Updated on 2026-04-29
20
Participants Needed
3
Research Sites
22 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are 40 years and older. The purpose of this study is to find out whether a medicine called pirfenidone changes the amount of a medicine called BI 1015550 in the blood. Some people may take more than one medicine at a time. Therefore, it is important to understand how different medicines influence one another. 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.
CONDITIONS
Official Title
A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 640 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 ICH-GCP and local legislation prior to admission to the trial
- Women of childbearing potential must be ready and able to use highly effective birth control methods, and if taking oral contraceptives, also use one barrier method
You will not qualify if you...
- Patients with a significant disease or condition other than IPF that may put the patient at risk or interfere with study procedures
- Acute IPF exacerbation within 1 month prior to Visit 1 and/or during screening
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2.5 x upper limit of normal (ULN) or total Bilirubin >1.5 x ULN at Visit 1
- Patients with underlying liver cirrhosis (Child Pugh C hepatic impairment)
- Severe hypertension uncontrolled under treatment 616/100 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
- Cholecystectomy or other gastrointestinal surgery that could affect drug pharmacokinetics (except appendectomy or simple hernia repair)
- Relevant chronic or acute infections including HIV and viral hepatitis
- Further exclusion criteria apply
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Renovatio Clinical-The Woodlands-69551
The Woodlands, Texas, United States, 77380
Actively Recruiting
2
LTD The First Medical Center
Tbilisi, Georgia, 0180
Actively Recruiting
3
LTD "Aversi clinic"
Tbilisi, Georgia, 160
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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