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

Description

This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in adolescents with psychiatric disorders.

Conditions

Psychiatric Disorders

Study Overview

Study Details

Study overview

This study is designed to assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses and ratios of xanomeline and trospium chloride in an IR capsule (KarXT) and dual-burst release of xanomeline with immediate-release trospium chloride in 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

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

Condition
Psychiatric Disorders
Intervention / Treatment

-

Contacts and Locations

Little Rock

Pillar Clinical Research- Little Rock, Little Rock, Arkansas, United States, 72204

Orange

NRC Research Institute, Orange, California, United States, 92868

Decatur

CenExel iResearch, LLC, Decatur, Georgia, United States, 30030

Overland Park

Dr. Vince Clinical Research, Overland Park, Kansas, United States, 66212

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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).
  • * 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.

Ages Eligible for Study

13 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Bristol-Myers Squibb,

Bristol Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2026-01-03