A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood

Phase 2

Not yet recruiting

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: BI 1015550; Drug: Pirfenidone

• Registration Number: NCT06241560
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Study First Posted: 2024-02-05
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-20
• Last Update Posted: 2025-05-21
• Study Start: 2025-06-06
• Primary Completion: 2025-10-20
• Study Completion: 2025-10-27

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BI 1015550, then Pirfenidone + BI 1015550	BI 1015550	-
BI 1015550, then Pirfenidone + BI 1015550	Pirfenidone	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to day 34
Maximum measured concentration of BI 1015550 in plasma (Cmax)	Up to day 34

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to day 34

Trial Locations

Locations (2)

LTD The First Medical Center; 🇬🇪 Tbilisi, Georgia

LTD "Aversi clinic"; 🇬🇪 Tbilisi, Georgia