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Effect of Pirfenidone on the Pharmacokinetics of BI 1015550 in IPF
NCT06241560Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2026
- Primary completion
- Aug 2026
- Countries
- 2
- Sponsor
- Boehringer Ingelheim
- Modality
- Small Molecules
- Drugs
- nerandomilast
- Conditions
- idiopathic pulmonary fibrosis (IPF)
01
Overview
Phase 2, open-label, single-arm trial of nerandomilast in idiopathic pulmonary fibrosis (IPF), sponsored by Boehringer Ingelheim. Primary endpoints: Area under the concentration-time curve from 0 to the last quantifiable data point and Maximum measured concentration. Started Mar 2026; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
BI 1015550, then Pirfenidone + BI 1015550
Participants receive a single dose of BI 1015550, followed by a 3-week titration of pirfenidone, and then another single dose of BI 1015550.
03
Who it enrols
Adults ≥40 years with idiopathic pulmonary fibrosis, BMI 18.5-29.9 kg/m^2, normal kidney function (eGFR ≥90), and no severe cardiovascular disease or recent acute IPF exacerbation.
04
Endpoints
Primary
Area under the concentration-time curve from 0 to the last quantifiable data point
Maximum measured concentration
Secondary
Area under the concentration-time curve from 0 extrapolated to infinity
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