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

Last updated: May 9, 2025
Sponsor: Bristol-Myers Squibb
Overall Status: Active - Recruiting

Phase

1

Condition

Schizotypal Personality Disorder (Spd)

Affective Disorders

Tic Disorders

Treatment

KarXT

KarX-EC

Clinical Study ID

NCT06853171
CN012-0022
  • Ages 13-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • LAR (ie, legal guardian or caregiver) must have signed and dated an IRB/IEC-approvedICF in accordance with regulatory, local, and institutional guidelines.

  • Confirmed Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, TextRevision (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, nopsychiatric hospitalization within the last 6 months; no imminent risk of suicide orinjury to self, others, or property).

Exclusion

Exclusion Criteria:

  • Any clinically significant neurological, metabolic (including type 1 diabetes),hepatic, renal, hematological, pulmonary, cardiovascular, GI (including activeobstructive GI disorders), carcinoma, active biliary disorders (eg, symptomaticgallstones) and/or urological disorder, congestive heart failure (uncontrolled), orCNS infection that would pose a risk to the participants if they were to participatein the study or that might confound the results of the study.

  • Participant has a risk for suicidal behavior during the study, as determined by theinvestigator's clinical judgment and C-SSRS.

  • eGFR < 60 mL/min.

  • History of Gilbert's Disease or history of liver disease (Child-Pugh class A andhigher).

  • History or high risk of urinary retention, gastric retention, or narrow-angleglaucoma.

  • Participants with history of bladder stones or recurrent UTIs.

  • Other protocol defined inclusion/exclusion criteria apply.

Study Design

Total Participants: 36
Treatment Group(s): 2
Primary Treatment: KarXT
Phase: 1
Study Start date:
April 29, 2025
Estimated Completion Date:
January 03, 2026

Connect with a study center

  • Local Institution - 0005

    Little Rock, Arkansas 72204
    United States

    Site Not Available

  • Pillar Clinical Research- Little Rock

    Little Rock, Arkansas 72204
    United States

    Active - Recruiting

  • Local Institution - 0006

    Orange, California 92868
    United States

    Site Not Available

  • NRC Research Institute

    Orange, California 92868
    United States

    Active - Recruiting

  • CenExel iResearch, LLC

    Decatur, Georgia 30030
    United States

    Active - Recruiting

  • Local Institution - 0007

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Dr. Vince Clinical Research

    Overland Park, Kansas 66212
    United States

    Active - Recruiting

  • Local Institution - 0008

    Overland Park, Kansas 66212
    United States

    Site Not Available

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