A Study to Evaluate Novel KarX and KarT Prototypes Versus the KarXT and KarX-EC Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

NCT ID: NCT07063342

Last Updated: 2025-12-19

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-27

Study Completion Date

2026-08-15

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride Capsule

Intervention Type DRUG

Specified dose on specified days

Xanomeline Enteric Capsule

Intervention Type DRUG

Specified dose on specified days

Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Part 2

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride Capsule

Intervention Type DRUG

Specified dose on specified days

Xanomeline Enteric Capsule

Intervention Type DRUG

Specified dose on specified days

Trospium Chloride

Intervention Type DRUG

Specified dose on specified days

Part 3

Group Type EXPERIMENTAL

Xanomeline/Trospium Chloride Capsule

Intervention Type DRUG

Specified dose on specified days

Xanomeline Enteric Capsule

Intervention Type DRUG

Specified dose on specified days

Interventions

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Xanomeline/Trospium Chloride Capsule

Specified dose on specified days

Intervention Type DRUG

Xanomeline Enteric Capsule

Specified dose on specified days

Intervention Type DRUG

Trospium Chloride

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986510 KarXT BMS-986519 KarX-EC BMS-986520 KarT

Eligibility Criteria

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Inclusion Criteria

* BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Quotient Sciences

Nottingham, Nottinghamshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Role: CONTACT

Phone: 855-907-3286

Email: [email protected]

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

Role: CONTACT

Facility Contacts

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Philip Evans, Site 0001

Role: primary

Related Links

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Other Identifiers

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U1111-1321-3511

Identifier Type: OTHER

Identifier Source: secondary_id

CN012-0043

Identifier Type: -

Identifier Source: org_study_id