Actively Recruiting
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
Led by Boehringer Ingelheim · Updated on 2026-05-26
96
Participants Needed
9
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how well adults with borderline personality disorder (BPD) or attention deficit/hyperactivity disorder (ADHD) tolerate a medicine called BI 3031185. The study includes separate groups for people with BPD and ADHD and aims to assess safety, tolerability, pharmacodynamics, and pharmacokinetics through a randomized, double-blind, placebo-controlled design. Participants take part in two sequences: one group receives a single dose of BI 3031185 followed by placebo after a two-week break, while the other group receives placebo first then BI 3031185. Both treatments are given as tablets. The study lasts about 1 to 2 months, with several visits including overnight stays at the study site. During the 6 in-person visits and 3 phone or video calls, doctors monitor participants' health and check for any unwanted effects. The main outcomes measured are the number of participants reporting adverse events related to the medicine. Safety and tolerability are closely observed from the time of dosing until the end of the study.
CONDITIONS
Brief Title
A Study to Test How BI 3031185 is Tolerated by People With Borderline Personality Disorder or Attention-deficit/Hyperactivity Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male, female, and non-binary participants aged 18 to 45 years at the time of consent
- Diagnosed with borderline personality disorder or attention-deficit/hyperactivity disorder as primary diagnosis confirmed by MINI at screening
- Willing to abstain from alcohol for 24 hours and other drugs of abuse including cannabis for 72 hours before Visits 2 and 3
- Willing to abstain from alcohol, cannabis for 72 hours and other recreational drugs during the trial
- Willing to stop prescribed psychostimulants 72 hours before Visits 2 and 3 and 24 hours after investigational medicinal product administration
- Further inclusion criteria apply
You will not qualify if you...
- Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, delusional disorder, autism spectrum disorder, or antisocial personality disorder
- Any psychiatric disorder not currently stable in symptoms and treatment
- Substance use disorder within 3 months prior to randomisation (except mild alcohol, cannabis, tobacco, caffeine) or moderate to severe substance use disorder within 6 months prior to randomisation (except tobacco and caffeine)
- Positive drug screen (except cannabis if not moderate/severe use disorder and not impeding participation)
- Use of psychotropic medications not allowed, except stable doses of a single SSRI or SNRI, a single low-dose second-generation antipsychotic, or a single stable sleep medication
- Psychostimulant medication for ADHD must be stopped as per protocol
- Active or suspected malignancy or malignancy history within 5 years except certain skin or cervical cancers
- Positive test for active hepatitis
- Previous randomisation in this trial
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 days
Participants receive BI 3031185 and placebo in a randomized crossover design to evaluate safety, tolerability, pharmacodynamics, and pharmacokinetics.
Multiple visits during treatment periods
Trial Site Locations
Total: 9 locations
1
Charité Research Organisation GmbH
Berlin, Germany, 10117
Actively Recruiting
2
Universitätsklinikum Bonn AöR
Bonn, Germany, 53127
Actively Recruiting
3
Technische Universität Dresden
Dresden, Germany, 01307
Not Yet Recruiting
4
Universitätsklinikum Frankfurt
Frankfurt am Main, Germany, 60590
Actively Recruiting
5
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany, 06112
Actively Recruiting
6
Universitätsklinikum Hamburg, Eppendorf
Hamburg, Germany, 20251
Not Yet Recruiting
7
Rheinhessen-Fachklinik Mainz
Mainz, Germany, 55122
Actively Recruiting
8
Zentralinstitut für seelische Gesundheit
Mannheim, Germany, 68159
Actively Recruiting
9
Universitätsklinikum Tübingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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