Clinical trial NCT06853171: Safety, Tolerability, and Pharmacokinetics of 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Psychiatric Disorders
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2025-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Adverse Events (AEs)
timeFrame: Up to Day 43
measure: Number of participants with Serioues AEs (SAEs)
timeFrame: Up to Day 43
measure: Number of participants with AEs of Special Interest (AESIs)
timeFrame: Up to Day 43
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 15
measure: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
timeFrame: Up to Day 15
measure: Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
timeFrame: Up to Day 15
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 15
measure: Concentration at the end of a dosing interval (Ctau)
timeFrame: Up to Day 15
measure: Cmax accumulation index (AI_Cmax)
timeFrame: Up to Day 15
measure: AUC accumulation index (AI_AUC)
timeFrame: Up to Day 15
measure: Ctau accumulation index (AI_Ctau)
timeFrame: Up to Day 15
measure: Average concentration within a dosing interval at steady-state (Css-avg)
timeFrame: Up to Day 15
measure: Apparent total body clearance (CLT/F)
timeFrame: Up to Day 15
measure: Effective elimination half-life during dosing interval (T-HALF(eff))
timeFrame: Up to Day 15
measure: T-HALFeff based on AUC observed (T-HALFeff_AUC)
timeFrame: Up to Day 15
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Pillar Clinical Research- Little Rock
state: Arkansas
city: Orange
country: United States
facility: NRC Research Institute
state: California
city: Decatur
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Overland Park
country: United States
facility: Dr. Vince Clinical Research
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol Myers Squibb
role: STUDY_DIRECTOR
References: