A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood
- Disease/Condition
- Idiopathic Pulmonary Fibrosis
- Drug/Device/Intervention
- BI 1015550
- Study type
- Interventional
- Intervention type
- drug
- Primary sponsor
- Boehringer Ingelheim
- Phase
- Phase 1
- Start date
- Jul 12, 2024
- End date
- Aug 15, 2025
- Enrollment
- 20 participants
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)
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.
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT06241560
- Type
- Non-Device Trial
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.