COMPLETED

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

Conditions

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-29

Study Completion:2025-07-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06853171

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.

Ages Eligible for Study:13 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Principal Investigator

Bristol Myers Squibb

STUDY_DIRECTOR

Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0005

Little Rock, Arkansas, 72204

United States

Local Institution - 0006

Orange, California, 92868

United States

Local Institution - 0007

Decatur, Georgia, 30030

United States

Local Institution - 0008

Overland Park, Kansas, 66212

United States

Collaborators and Investigators

Sponsor: Bristol-Myers Squibb

Bristol Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-29

Study Completion Date2025-07-22

Study Record Updates

Study Start Date2025-04-29

Study Completion Date2025-07-22

Terms related to this study

Additional Relevant MeSH Terms

Psychiatric Disorders