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

Phase 1

Recruiting

• Conditions: Psychiatric Disorders
• Interventions: Drug: KarXT; Drug: KarX-EC

• Registration Number: NCT06853171
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-02-25
• Study First Posted: 2025-02-28
• Study Start: 2025-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2026-01-03
• Study Completion: 2026-01-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 3	KarXT	-
Cohort 1	KarXT	-
Cohort 2	KarXT	-
Cohort 2	KarX-EC	-
Cohort 3	KarX-EC	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
AUC accumulation index (AI_AUC)	Up to Day 15	Ratio of area under the concentration-time curve in 1 dosing interval at steady-state on Day 5 to area under the concentration-time curve in 1 dosing interval after first dose
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
Cmax accumulation index (AI_Cmax)	Up to Day 15	Ratio of maximum observed plasma concentration at steady-state on Day 5 to maximum observed plasma concentration after first dose
Ctau accumulation index (AI_Ctau)	Up to Day 15	Ratio of concentration at the end of the dosing interval at steady-state on Day 5 to maximum observed plasma concentration after first dose
Average concentration within a dosing interval at steady-state (Css-avg)	Up to Day 15
Apparent total body clearance (CLT/F)	Up to Day 15
Effective elimination half-life during dosing interval (T-HALF(eff))	Up to Day 15
T-HALFeff based on AUC observed (T-HALFeff_AUC)	Up to Day 15	Effective elimination half-life based on degree of area under the plasma concentration-time curve accumulation observed

Trial Locations

Locations (4)

Pillar Clinical Research- Little Rock; 🇺🇸 Little Rock, Arkansas, United States

NRC Research Institute; 🇺🇸 Orange, California, United States

CenExel iResearch, LLC; 🇺🇸 Decatur, Georgia, United States

Dr. Vince Clinical Research; 🇺🇸 Overland Park, Kansas, United States