Pirfenidone's effect on BI 1015550 blood levels in people with idiopathic pulmonary fibrosis
An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550
This study sees if taking pirfenidone changes how much BI 1015550 is in the blood of people aged 40 and older with idiopathic pulmonary fibrosis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 3 sites (The Woodlands, Texas and 2 other locations) |
| Trial ID | NCT06241560 on ClinicalTrials.gov |
What this trial studies
Adults with idiopathic pulmonary fibrosis receive a single dose of BI 1015550, then start pirfenidone with a stepwise increase over three weeks, followed by another BI 1015550 dose to compare blood levels. The trial measures drug concentrations over time to determine whether pirfenidone alters the pharmacokinetics of BI 1015550. Participants attend about 15 visits over a little more than one month, including two overnight stays and phone follow-ups. Safety and tolerability are monitored throughout.
Who should consider this trial
Good fit: Adults aged 40 or older with a diagnosis of idiopathic pulmonary fibrosis who are suitable for pirfenidone treatment and meet BMI and contraceptive requirements are ideal candidates.
Not a fit: Patients with acute IPF or other significant medical conditions that increase risk or interfere with participation are unlikely to benefit from joining this pharmacokinetic study.
Why it matters
Potential benefit: If successful, the results could help clinicians know whether dosing adjustments or precautions are needed when patients take both drugs together.
How similar studies have performed: Drug–drug interaction studies are a standard, well-established method and have shown clinically important effects for other antifibrotic combinations, but the specific interaction between BI 1015550 and pirfenidone has not been fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * 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 criteria: * 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 * Further exclusion criteria apply
Where this trial is running
The Woodlands, Texas and 2 other locations
- Renovatio Clinical-The Woodlands-69551 — The Woodlands, Texas, United States (Recruiting)
- LTD The First Medical Center — Tbilisi, Georgia (Recruiting)
- LTD "Aversi clinic" — Tbilisi, Georgia (Recruiting)
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.