This Study in Healthy Men Tests How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 1358894 Affects the Way the Body Breaks Down Midazolam

Phase 1 Completed 50 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The primary objective of the trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of multiple rising doses over 14 days.

Timeline

Start: 2018-12-18
Primary completion: 2019-07-22
Completion: 2019-07-22

Publications

Fuertig R, Goettel M, Herich L, Hoefler J, Wiebe ST, Sharma V. Effects of Single and Multiple Ascending Doses of BI 1358894 in Healthy Male Volunteers on Safety, Tolerability and Pharmacokinetics: Two Phase I Partially Randomised Studies. CNS Drugs. 2023 Dec;37(12):1081-1097. doi: 10.1007/s40263-023-01041-4. Epub 2023 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 1358894	Small molecule	10 mg	Oral
Subject	BI 1358894	Small molecule	25 mg	Oral
Subject	BI 1358894	Small molecule	50 mg	Oral
Subject	BI 1358894	Small molecule	100 mg	Oral
Subject	BI 1358894	Small molecule	200 mg	Oral
Subject	Midazolam	Small molecule	—	—

Indications

No indication recorded.