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Trials / Completed

CompletedNCT06070610

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood

The Effect of Multiple Oral Doses of BI 1015550 on the Pharmacokinetics of Nintedanib and Pirfenidone Administered Single Dose to Healthy Male Subjects (Open-label, Two-period, Fixed-sequence Crossover Trial)

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
14 (actual)
Sponsor
Boehringer Ingelheim · Industry
Sex
Male
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

The main objective of this trial is to investigate the induction effect of multiple oral doses of BI 1015550 on the pharmacokinetics of nintedanib or pirfenidone.

Conditions

Interventions

TypeNameDescription
DRUGBI 1015550BI 1015550
DRUGNintedanibSoft capsules
DRUGPirfenidoneFilm-coated tablets

Timeline

Start date
2023-11-08
Primary completion
2023-12-14
Completion
2023-12-14
First posted
2023-10-06
Last updated
2025-12-02
Results posted
2025-12-02

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT06070610. Inclusion in this directory is not an endorsement.

A Study in Healthy Men to Test Whether BI 1015550 Influences the Amount of Nintedanib and Pirfenidone in the Blood (NCT06070610) · Clinical Trials Directory