A Study in Healthy Japanese Men to Test How Well Different Doses of BI 764198 Are Tolerated

Phase 1 Completed 44 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

The main objectives of this trial are to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single dose and multiple rising doses per day over 14 days. Secondary objectives are the exploration of pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing.

Timeline

Start: 2021-02-06
Primary completion: 2021-10-16
Completion: 2021-10-16

Publications

Yonemura T, Sarashina A, Tachibana Y, Retlich S, Soleymanlou N. A randomized, Phase I study of the safety, tolerability, and pharmacokinetics of BI 764198, a transient receptor potential channel 6 (TRPC6) inhibitor, in healthy Japanese men. Expert Opin Investig Drugs. 2025 May;34(5):425-433. doi: 10.1080/13543784.2025.2510664. Epub 2025 Jun 3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 764198	Unknown	20 mg	Oral
Subject	BI 764198	Unknown	40 mg	Oral
Subject	BI 764198	Unknown	80 mg	Oral
Subject	BI 764198	Unknown	160 mg	Oral

Indications

No indication recorded.