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

Part of paid clinical trials in The Woodlands, Texas.

Sponsor
Boehringer Ingelheim
Study ID
NCT06241560
Phase
PHASE2
Status
Recruiting
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Conditions

  • Idiopathic Pulmonary Fibrosis

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BI 1015550 — DRUG
    BI 1015550
  • Pirfenidone — DRUG
    Pirfenidone

Study Details

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.

Key Dates

Start date
Mar 5, 2026
Status verified
Apr 2026
Primary completion
Aug 4, 2026
Completion
Aug 6, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BI 1015550, then Pirfenidone + BI 1015550

Primary Outcome Measure

Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) [ Time Frame: Up to day 34 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Renovatio Clinical-The Woodlands-69551The WoodlandsTexas77380
Boehringer Ingelheim
[email protected]
833-602-2368

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Renovatio Clinical-The Woodlands-69551· The Woodlands, TX

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