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

NCT07001475 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-15

No results posted yet for this study

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

DRUG

BI 3031185

BI 3031185

DRUG

Placebo

Placebo matching BI 3031185

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-12
Primary Completion
2026-10-27
Completion
2026-11-27

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07001475 on ClinicalTrials.gov