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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BI 1015550, then Pirfenidone + BI 1015550 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 1015550 | Drug | BI 1015550 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) | Up to day 34 |
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Inclusion criteria:
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:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim | Contact | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Renovatio Clinical-The Woodlands-69551 | Recruiting | The Woodlands | Texas | 77380 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| Pirfenidone | Drug | Pirfenidone |
|
|
| LTD The First Medical Center | Recruiting | Tbilisi | 0180 | Georgia |
|
| LTD "Aversi clinic" | Recruiting | Tbilisi | 160 | Georgia |
|
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000727475 | BI 1015550 |
| C093844 | pirfenidone |
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