Assessing the safety and effects of a new medication for adolescents with psychiatric disorders
An Open-label, Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
This study is testing a new medication for teenagers with mental health issues to see if it's safe and how well it works for them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 13 Years to 17 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 4 sites (Little Rock, Arkansas and 3 other locations) |
| Trial ID | NCT06853171 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, tolerability, and pharmacokinetics of a new treatment combining xanomeline and trospium chloride in adolescents diagnosed with various psychiatric disorders. Participants will receive multiple doses of the medication to determine its effects and how well it is tolerated. The study aims to provide insights into the pharmacological profile of this combination therapy in a young population with specific mental health conditions.
Who should consider this trial
Good fit: Ideal candidates are adolescents diagnosed with schizophrenia, bipolar disorder, ADHD, Tourette's disorder, or autism spectrum disorder who are clinically stable.
Not a fit: Patients with significant neurological, metabolic, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for adolescents suffering from psychiatric disorders.
How similar studies have performed: While this approach is novel, similar studies have explored pharmacological treatments for psychiatric disorders with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Little Rock, Arkansas and 3 other locations
- Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (Recruiting)
- NRC Research Institute — Orange, California, United States (Recruiting)
- CenExel iResearch, LLC — Decatur, Georgia, United States (Recruiting)
- Dr. Vince Clinical Research — Overland Park, Kansas, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 8559073286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.