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

Bristol-Myers Squibb (BMS)

Status and phase: Enrolling; Phase 1

Conditions: Psychiatric Disorders

Treatments: Drug: KarX-EC; Drug: KarXT

Study type: Interventional

Funder types: Industry

Identifiers

NCT06853171

CN012-0022

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 13 to 17 years old

Volunteers: No Healthy Volunteers

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:

  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).

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Cohort 1

Experimental group

Treatment:

Drug: KarXT

Cohort 2

Experimental group

Treatment:

Drug: KarXT

Drug: KarX-EC

Cohort 3

Experimental group

Treatment:

Drug: KarXT

Drug: KarX-EC