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
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.
• Male, female, and non-binary participants, 18 to 45 years of age, both inclusively, at the time of consent
• Meet current Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria as primary diagnosis as assessed by the Mini International Neuropsychiatric Interview (MINI) at screening for borderline personality disorder (BPD) OR attention-deficit/hyperactivity disorder (ADHD)
• Willingness to abstain from alcohol for 24 h, and all other drugs of abuse including cannabis for 72 h prior to Visits 2 and 3 (Day -1). Willingness to abstain from alcohol and cannabis for 72 h after investigational medicinal product (IMP) administration, as well as from all other recreational drugs for the duration of the trial
• Willingness to abstain from prescribed psychostimulants for 72 h prior to Visits 2 and 3 (Day -1) and 24 h following IMP administration Further inclusion criteria apply