A Study in Healthy Men to Measure the Amount of BI 425809 in the Blood When Taken as a Tablet

Phase 1 Completed 6 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate the absolute oral bioavailability of BI 425809 administered as tablet (Test, T) compared to \[C-14\]-BI 425809 administered as intravenous microtracer (Reference, R).

Timeline

Start: 2019-01-15
Primary completion: 2019-03-06
Completion: 2019-03-06

Publications

Burkard U, Desch M, Shatillo Y, Wunderlich G, Mack SR, Schlecker C, Teitelbaum AM, Liu P, Chan TS. The Absolute Bioavailability, Absorption, Distribution, Metabolism, and Excretion of BI 425809 Administered as an Oral Dose or an Oral Dose with an Intravenous Microtracer Dose of [14C]-BI 425809 in Healthy Males. Clin Drug Investig. 2022 Jan;42(1):87-99. doi: 10.1007/s40261-021-01111-9. Epub 2021 Dec 22.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Iclepertin	Small molecule	30 ug	Oral
Subject	Iclepertin	Small molecule	25 mg	Oral

Indications

No indication recorded.