Boehringer Ingelheim pauses phase 1 trial of BI 3031185 in Japan to investigate safety event

Boehringer Ingelheim has placed a phase 1 study of its investigational oral small‑molecule candidate BI 3031185 on voluntary hold after a safety event was reported.

The trial, which began in early July at a hospital in Fukuoka, Japan, consists of two parts: a single‑blind, placebo‑controlled safety and pharmacokinetic assessment in healthy male volunteers, and a non‑randomized, open‑label evaluation of the drug’s effect on the pharmacokinetics of Bayer’s oral contraceptive Yaz in healthy female participants.

The company said patient safety is paramount and that it is evaluating the incident, but did not disclose details about the nature of the safety event or the drug’s mechanism of action. Boehringer said it will provide an update once the assessment is complete.