A Study in Healthy People to Test How BI 425809 is Taken up in the Body When Taken With or Without Food

Phase 1 Completed 16 enrolled Boehringer Ingelheim

RandomizedCrossoverOpen-labelTreatment

Summary

The main objective of this trial is to investigate the potential effect of food on the pharmacokinetics of BI 425809 following administration of the intended Commercial Formulation (iCF) with food (Test treatment, T) and without food (Reference treatment, R).

Timeline

Start: 2022-10-25
Primary completion: 2022-12-28
Completion: 2022-12-28

Publications

Madari S, Breithaupt-Groegler K, English BA, Hohl K, Jungnik A, Desch M. Assessing the Effect of Food on the Pharmacokinetics of Iclepertin in Healthy Volunteers: A Phase I, Open-Label, Randomised, Cross-over Trial. Eur J Drug Metab Pharmacokinet. 2025 Sep;50(5):399-408. doi: 10.1007/s13318-025-00956-1. Epub 2025 Jul 17.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iclepertin	Small molecule	10 mg	Oral

Indications

No indication recorded.