Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
NCT ID: NCT06853171
Last Updated: 2025-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2025-04-29
2025-07-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
KarXT
Specified dose on specified days
Cohort 2
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Cohort 3
KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
KarX-EC
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
13 Years
17 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0005
Little Rock, Arkansas, United States
Local Institution - 0006
Orange, California, United States
Local Institution - 0007
Decatur, Georgia, United States
Local Institution - 0008
Overland Park, Kansas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CN012-0022
Identifier Type: -
Identifier Source: org_study_id
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