NCT07001475

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

A Phase Ib, Multicentre, Randomised, Double Blind, Placebo Controlled, 2 Sequence Crossover Trial to Evaluate the Effects of BI 3031185 on Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics in Patients With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with borderline personality disorder (BPD) and with attention deficit/ hyperactivity disorder (ADHD). The purpose of this study is to find out how a medicine called BI 3031185 is tolerated by people with BPD or ADHD. Participants with BPD with ADHD are in separate cohorts. Participants from each cohort 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 1 to 2 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.

Conditions

• Borderline Personality Disorder
• Attention Deficit Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	BI 3031185	BI 3031185
DRUG	Placebo	Placebo matching BI 3031185

Timeline

• Start date: 2025-08-12
• Primary completion: 2026-10-27
• Completion: 2026-11-27
• First posted: 2025-06-03
• Last updated: 2026-04-15

Locations

12 sites across 1 country: Germany