Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders

Launched by BRISTOL-MYERS SQUIBB · Feb 25, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for adolescents with certain psychiatric disorders, including schizophrenia, bipolar disorder, ADHD, Tourette's disorder, and autism spectrum disorder. The study will look at the safety and how well the body processes a combination of two medications: xanomeline and trospium chloride, given in different ways. The goal is to see how these medications work together and to determine if they are safe for young people who are stable in their mental health.

To participate, adolescents aged 12 to 17 must have a confirmed psychiatric diagnosis and be stable, meaning they haven’t had any hospital stays for their condition in the past six months and are not at risk of harming themselves or others. Participants will need to be assessed by a healthcare professional to ensure they meet certain health criteria. If someone joins this trial, they can expect to take the medications as described, with close monitoring for any side effects or reactions. It’s important to note that the trial is not yet recruiting participants, so those interested will need to wait until it officially begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approved ICF in accordance with regulatory, local, and institutional guidelines.
• * Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) psychiatric diagnosis of 1 of the following:
• • 1. Schizophrenia or schizoaffective disorder
• • 2. Bipolar I or II disorder
• • 3. Attention-deficit/hyperactivity disorder (ADHD)
• • 4. Tourette's disorder
• • 5. Autism spectrum disorder (ASD)
• • Participant is judged by the investigator to be clinically stable (eg, no psychiatric hospitalization within the last 6 months; no imminent risk of suicide or injury to self, others, or property).
• Exclusion Criteria:
• • Any clinically significant neurological, metabolic (including type 1 diabetes), hepatic, renal, hematological, pulmonary, cardiovascular, GI (including active obstructive GI disorders), carcinoma, active biliary disorders (eg, symptomatic gallstones) and/or urological disorder, congestive heart failure (uncontrolled), or CNS infection that would pose a risk to the participants if they were to participate in the study or that might confound the results of the study.
• • Participant has a risk for suicidal behavior during the study, as determined by the investigator's clinical judgment and C-SSRS.
• • eGFR \< 60 mL/min.
• • History of Gilbert's Disease or history of liver disease (Child-Pugh class A and higher).
• • History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
• • Participants with history of bladder stones or recurrent UTIs.
• • Other protocol defined inclusion/exclusion criteria apply.