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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

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Xanomeline/Trospium Chloride Capsule (drug), Xanomeline Enteric Capsule (drug), Trospium Chloride (drug), Xanomeline MR (drug)
How long the study runs: Study runs about 21 months (dates as stated)
About the drug or intervention: Xanomeline/Trospium Chloride Capsule — drug: Specified dose on specified days · Xanomeline Enteric Capsule — drug: Specified dose on specified days · Trospium Chloride — drug: Specified dose on specified days · Xanomeline MR — drug: Specified dose on specified days · Xanomeline — drug: Specified dose on specified days · Placebo — drug: Specified dose on specified days
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 18 Years to 55 Years
Who: All
Number of participants: 236
Started: 2025-06-27
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for healthy volunteers
• Phase1 - 236 participants
• The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants

Who can take part?

• Ages 18 Years to 55 Years
• Diagnosed with healthy volunteers

Where?

• Nottingham - Quotient Sciences

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The purpose of this study is to evaluate novel KarX and KarT prototypes versus the KarXT and KarX-EC reference following single doses, to explore the effect of food after multiple doses of selected prototypes, and to evaluate alternative formulations of KarX and KarXT following single and multiple ascending doses in healthy adult participants.

Healthy Volunteers

How this trial compares with your answers

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What we know so far

Condition· Matched your search

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Gender· Tell us your sex for better matching

Still need:

• Tell us your age for better matching
• Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 18 Years - 55 Years
Who can join: All genders

What the study is looking for

✓BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
✓Other protocol-defined Inclusion/Exclusion criteria apply.

See the full criteria

Inclusion Criteria: * BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening. * Other protocol-defined Inclusion/Exclusion criteria apply.

Where Is This Study? (1 UK site)

Quotient Sciences

Nottingham NG1 6JS, United Kingdom

Recruiting

Site contact (verified)

Philip Evans, Site 00014401159749000

How to Get in Touch

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Sponsor contact

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-08