A Study to Test How Well Healthy Men Tolerate Different Doses of BI 764198

Phase 1 Completed 52 enrolled Boehringer Ingelheim

RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of multiple rising doses per day over 14 days and to explore the pharmacokinetics (PK) of BI 764198 after single and multiple oral dosing. In addition, the effect of BI 764198 on the pharmacokinetics of midazolam, given as an oral microdose, will be explored after multiple oral dosing.

Timeline

Start: 2019-10-29
Primary completion: 2020-10-08
Completion: 2020-10-08

Publications

Schultz A, Halabi A, Seitz F, Lemmens K, Wulfrath HS, Lobmeyer MT, Retlich S, Choi W, Soleymanlou N. Phase 1 trials of BI 764198, a transient receptor potential channel 6 inhibitor, in healthy volunteers and participants with kidney impairment. Expert Opin Investig Drugs. 2025 May;34(5):415-423. doi: 10.1080/13543784.2025.2510673. Epub 2025 Jun 8.

Drugs

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

Indications

No indication recorded.