Actively Recruiting
An Open-label, Single-group Trial to Evaluate How Pirfenidone Affects BI 1015550 Levels in Adults With Idiopathic Pulmonary Fibrosis
Led by Boehringer Ingelheim · Updated on 2026-04-29
20
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 40 years and older who have idiopathic pulmonary fibrosis (IPF) to find out whether the medicine pirfenidone affects the levels of another medicine called BI 1015550 in the blood. The study aims to understand how these two medicines interact when taken together, which is important since patients may take more than one medicine at a time. This is a Phase 2 trial sponsored by Boehringer Ingelheim. Participants first take a single dose of BI 1015550 as a tablet. Then, they start taking pirfenidone tablets three times a day, starting with one tablet per dose during the first week, increasing to two tablets per dose in the second week, and three tablets per dose in the third week. After this dose escalation, participants take another single dose of BI 1015550. The study is open-label and involves one treatment group. Participants will be involved in the study for a little over one month, during which they will visit the study site 15 times. Two of these visits include overnight stays. Researchers will collect health information and take blood samples to measure the amounts of pirfenidone and BI 1015550 in the blood. Throughout the study, participants' health is regularly checked, and any side effects are carefully recorded. The main outcomes measured are the concentration levels of BI 1015550 in the plasma over time.
CONDITIONS
Brief 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 60 years or older at the time of consent
- Diagnosis of idiopathic pulmonary fibrosis (IPF) with indication or no contraindication for pirfenidone treatment
- Body mass index (BMI) between 18.5 and 29.9 kg/m
- Signed informed consent according to ICH-GCP and local laws
- Women of childbearing potential must use effective birth control methods, including one barrier method if taking oral contraceptives
You will not qualify if you...
- Significant diseases other than IPF that may increase risk or interfere with study participation
- Acute IPF exacerbation within 1 month before screening
- Elevated liver enzymes (AST or ALT >2.5 times upper limit of normal) or bilirubin >1.5 times upper limit at screening
- Liver cirrhosis classified as Child Pugh C
- Cardiovascular conditions including severe uncontrolled hypertension, recent myocardial infarction, stroke, transient ischemic attack, or unstable angina within specified recent periods
- Chronic kidney disease with eGFR less than 90 ml/min/1.73 m at screening
- History of gastrointestinal surgeries that affect drug absorption except appendectomy or simple hernia repair
- Active or chronic infections including HIV and viral hepatitis
- Other relevant exclusion criteria as per study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 34 days
Participants receive BI 1015550 alone followed by a combination of Pirfenidone and BI 1015550 to evaluate how Pirfenidone affects BI 1015550 levels in the blood.
Multiple visits during treatment up to Day 34
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
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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