Clinical Trial

A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder

Completed Phase 1

Summary

This study is open to adults with certain mental health conditions. The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with certain mental health conditions. Participants are put into 2 groups of equal size randomly, which means by chance. Group 1 takes a single dose of BI 3031185 and Group 2 takes placebo. After a 2-week break, Group 1 takes placebo and Group 2 takes a single dose of BI 3031185. Participants take BI 3031185 and placebo as tablets. Participants are in the study for about 3 months. They visit the study site 6 times and have 3 phone or video call visits. For 2 of the visits, participants stay overnight at the study site for 2 nights. During all the visits, doctors check participants' health and take note of any unwanted effects.

Protocol Amendment History 9 changes

critical Trial completed 2026-08-11

critical Trial status changed: Recruiting → Active, Not Recruiting 2026-07-16

notable Enrollment increased: 68 -> 78 participants 2026-07-16

notable Primary completion moved earlier: 2026-10-27 -> 2026-08-11 2026-07-16

minor Completion moved earlier: 2026-11-27 -> 2026-08-11 2026-07-16

notable Enrollment reduced: 96 -> 68 participants 2026-06-16

minor Trial arms changed: 4 -> 2 2026-06-16

notable Trial sites reduced: 12 -> 9 locations 2026-05-27

notable Trial sites expanded: 7 -> 12 locations 2026-04-16

Trial Details

NCT Number	NCT07001475
Lead Sponsor	Boehringer Ingelheim
Conditions	Borderline Personality Disorder, Attention Deficit Hyperactivity Disorder
Enrollment	78 participants
Start Date	2025-08-12
Primary Completion	2026-08-06 (estimated)
Study Completion	2026-08-06 (estimated)
Updated on ClinicalTrials.gov	2026-08-10