A Study in Healthy Men to Find Out How BI 425809 is Taken up and Handled by the Body

Phase 1 Completed 6 enrolled Boehringer Ingelheim

NaSingle-groupOpen-labelTreatment

Summary

This trial intends to investigate the basic pharmacokinetics of BI 425809 and \[14C\]- radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 25 mg BI 425809 (C-14) given to healthy male subjects

Timeline

Start: 2018-09-11
Primary completion: 2018-11-12
Completion: 2018-11-12

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	3.7 mbq	Oral
Subject	Iclepertin	Small molecule	25 mg	Oral

Indications

No indication recorded.