Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT06241560
Eligibility 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 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
* Further exclusion criteria apply
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT06241560
Study Brief:
Protocol Section:
NCT06241560