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 Looks at How Food Influences the Amount of BI 1358894 in the Blood

Phase 1 Completed 83 enrolled Boehringer Ingelheim

RandomizedParallel-groupSingle-blindTreatment

Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 1358894 in healthy male subjects following oral administration of single rising doses. Secondary objectives are the exploration of the pharmacokinetics (PK), including dose proportionality of BI 1358894 after single dosing.

Timeline

Start: 2017-07-18
Primary completion: 2019-02-18
Completion: 2019-02-18

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	3 mg	Oral
Subject	BI 1358894	Small molecule	6 mg	Oral
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

Indications

No indication recorded.