Safety, Tolerability, and Pharmacokinetics of KarXT and Dual-burst Release of Xanomeline With Immediate-release Trospium Chloride in Adolescents With Psychiatric Disorders
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Phase
Phase 1
Status
Completed
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
24actual
Sites
4
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-04-29 | actual | When the study began enrolling |
| Primary completion | 2025-07-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-22 | actual | The whole study's end, after follow-up |
| First posted | 2025-02-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Psychiatric Disorders
Interventions
- Drug: KarXT — also filed as Xanomeline and Trospium Chloride Capsule, BMS-986510
- Drug: KarX-EC — also filed as Xanomeline Enteric-coated, BMS-986519
Primary outcomes
what the primary-completion date above is the date OFNumber of participants with Adverse Events (AEs)
measured Up to Day 43
Number of participants with Serioues AEs (SAEs)
measured Up to Day 43
Number of participants with AEs of Special Interest (AESIs)
measured Up to Day 43
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