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

NCT06853171 | Completed Phase 1 FDA Drug

• 1 other identifier: CN012-0022
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 4

Brief Summary

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with Adverse Events (AEs)

  Up to Day 43

• Number of participants with Serioues AEs (SAEs)

  Up to Day 43

• Number of participants with AEs of Special Interest (AESIs)

  Up to Day 43

Secondary Outcomes (12)

• Maximum observed plasma concentration (Cmax)

  Up to Day 15

• Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

  Up to Day 15

• Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

  Up to Day 15

• Time of maximum observed plasma concentration (Tmax)

  Up to Day 15

• Concentration at the end of a dosing interval (Ctau)

  Up to Day 15

Study Arms (3)

Cohort 1

EXPERIMENTAL

Drug: KarXT

Cohort 2

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC

Cohort 3

EXPERIMENTAL

Drug: KarXT; Drug: KarX-EC

Interventions

KarXT DRUG

Specified dose on specified days

Also known as: Xanomeline and Trospium Chloride Capsule, BMS-986510

Cohort 1; Cohort 2; Cohort 3

KarX-EC DRUG

Specified dose on specified days

Also known as: Xanomeline Enteric-coated, BMS-986519

Cohort 2; Cohort 3

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (4)

Local Institution - 0005

Little Rock, Arkansas, 72204, United States

Location

Local Institution - 0006

Orange, California, 92868, United States

Location

Local Institution - 0007

Decatur, Georgia, 30030, United States

Location

Local Institution - 0008

Overland Park, Kansas, 66212, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Mental Disorders

Interventions

xanomeline; trospium chloride

Study Officials

• Bristol Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: February 28, 2025
• Study Start: April 29, 2025
• Primary Completion: July 22, 2025
• Study Completion: July 22, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

US (4)