A Boehringer Ingelheim Phase I multiple rising dose trial evaluating the investigational oral CNS compound BI 3031185 has been suspended following a safety event, according to an update to ClinicalTrials.gov. The registry does not disclose the nature of the event, its severity, or whether it was considered related to the study drug.
The suspended study (NCT06916702), conducted at Charité Research Organisation GmbH in Berlin, was a single-blind, randomized, placebo-controlled parallel-group trial designed to characterize the safety, tolerability, and pharmacokinetics of BI 3031185 at multiple ascending oral doses in healthy adults. Part A enrolled healthy males across six dose groups, each receiving BI 3031185 or placebo alongside midazolam as a CYP3A4 probe substrate to assess drug-drug interaction potential. Part B was to extend dosing to women of non-childbearing potential. The registry lists a planned enrollment count of 100 and a target completion date of October 2026. No results have been posted. The registry does not establish whether the safety event was treatment-related, which treatment arm was affected, or whether dose escalation had been completed.
No public statement from the company addressing the suspension has been identified in available sources.