A Study About How Different Doses of BI 1358894 Are Taken up in the Body and How Well They Are Tolerated in Healthy Japanese Men

Phase 1 Completed 24 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PK) of BI 1358894 in healthy male subjects following oral administration of single rising doses.

Timeline

Start: 2019-03-25
Primary completion: 2019-07-20
Completion: 2019-07-20

Publications

Yoon J, Sharma V, Harada A. Safety, Tolerability, and Pharmacokinetics of Oral BI 1358894 in Healthy Japanese Male Volunteers. Clin Drug Investig. 2024 May;44(5):319-328. doi: 10.1007/s40261-024-01357-z. Epub 2024 Apr 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
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.