A Study in Healthy Men to Test Whether BI 1358894 Reduces Druginduced Panic Symptoms

Phase 1 Completed 20 enrolled Boehringer Ingelheim

RandomizedCrossoverDouble-blindTreatment

Summary

The main objective of this trial is to investigate the pharmacodynamic effects of a single dose of BI 1358894 on CCK-4- induced anxiogenic/ panic-like symptoms using the PSS in preselected CCK-4 sensitive healthy volunteers.

Timeline

Start: 2019-04-18
Primary completion: 2019-08-29
Completion: 2019-08-29

Publications

Goettel M, Fuertig R, Mack SR, Just S, Sharma V, Wunder A, den Boer J. Effect of BI 1358894 on Cholecystokinin-Tetrapeptide (CCK-4)-Induced Anxiety, Panic Symptoms, and Stress Biomarkers: A Phase I Randomized Trial in Healthy Males. CNS Drugs. 2023 Dec;37(12):1099-1109. doi: 10.1007/s40263-023-01042-3. Epub 2023 Nov 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	BI 1358894	Small molecule	100 mg	Oral

Indications

No indication recorded.