A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, Explore the Effect of Food After Multiple Doses of Selected Prototypes, and Evaluate Alternative Formulations of KarX and KarXT Following Single and Multiple Ascending Doses
← catalyst calendarNCT07063342 · readout in 222 d
Sponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
236estimated
Sites
1
Country
United Kingdom
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 | 2025-06-27 | actual | When the study began enrolling |
| Primary completion | 2027-03-29 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-03-29 | estimated | The whole study's end, after follow-up |
| First posted | 2025-07-14 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Healthy Volunteers
Interventions
- Drug: Xanomeline/Trospium Chloride Capsule — also filed as BMS-986510, KarXT
- Drug: Xanomeline Enteric Capsule — also filed as BMS-986519, KarX-EC
- Drug: Trospium Chloride — also filed as BMS-986520, KarT
- Drug: Xanomeline MR — also filed as BMS-986519, KarX-MR
- Drug: Xanomeline — also filed as BMS-986519, KarX
- Drug: Placebo
Primary outcomes
what the primary-completion date above is the date OFMaximum observed concentration (Cmax)
measured Up to Day 23
Time of maximum observed concentration (Tmax)
measured Up to Day 23
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
measured Up to Day 23
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
measured Up to Day 23
Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
measured Up to Day 23
Concentration at the end of a dosing interval (Ctau)
measured Up to Day 23
Apparent total body clearance (CLT/F)
measured Up to Day 23
Effective elimination half-life during dosing interval (T-HALF(eff))
measured Up to Day 23
Number of participants with Treatment Emergent Adverse Events (TEAEs)
measured Up to 30 days after final dose of study intervention
Number of participants with Serious Adverse Events (SAEs)
measured Up to 30 days after final dose of study intervention
Number of participants with Adverse Events of Special Interest (AESIs)
measured Up to 30 days after final dose of study intervention
Number of participants with AEs leading to discontinuation
measured Up to 30 days after final dose of study intervention
Columbia-Suicide Severity Rating Scale (C-SSRS)
measured Up to Day 14
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