NCT06241560

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

An Open-label, Single-group Trial to Evaluate the Effect of Pirfenidone on the Pharmacokinetics of a Single Oral Dose of BI 1015550
Boehringer Ingelheim·Phase 1·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
BI 1015550
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Boehringer Ingelheim
Timeline & enrollment
Phase
Phase 1
Start date
Jul 12, 2024
End date
Aug 15, 2025
Enrollment
20 participants
Primary outcome

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),Maximum measured concentration of BI 1015550 in plasma (Cmax)

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.

ICD-10 classifications
Other interstitial pulmonary diseases with fibrosisCystic fibrosis with pulmonary manifestationsCystic fibrosisGraphite fibrosis (of lung)Pulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06241560
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06241560 through Pure Global AI's free database. This Phase 1 trial is sponsored by Boehringer Ingelheim and is currently Not yet recruiting. The study focuses on Idiopathic Pulmonary Fibrosis. Target enrollment is 20 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.