drugset / Trial / NCT07001475

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

NCT07001475

Phase 1 Active not recruiting 78 enrolled Boehringer Ingelheim
RandomizedCrossoverQuadruple-blindTreatment

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.

Timeline

Start
2025-08-12
Primary completion
2026-08-11
Completion
2026-08-11

Drugs

EvaluationDrugModalityDoseRoute
Subject BI 3031185 Unknown Oral