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

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:

• Schizophrenia or schizoaffective disorder
• Bipolar I or II disorder
• Attention-deficit/hyperactivity disorder (ADHD)
• Tourette's disorder
• 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.