NCT07063342

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1 healthy-volunteers

Timeline
3mo left

Started Jun 2025

Longer than P75 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Jun 2025Aug 2026

First Submitted

Initial submission to the registry

June 23, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

June 27, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 14, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

1.1 years

First QC Date

June 23, 2025

Last Update Submit

December 15, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (8)

  • Maximum observed concentration (Cmax)

    Up to Day 23

  • Time of maximum observed concentration (Tmax)

    Up to Day 23

  • Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))

    Up to Day 23

  • Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))

    Up to Day 23

  • Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Up to Day 23

  • Concentration at the end of a dosing interval (Ctau)

    Up to Day 23

  • Apparent total body clearance (CLT/F)

    Up to Day 23

  • Effective elimination half-life during dosing interval (T-HALF(eff))

    Up to Day 23

Secondary Outcomes (13)

  • Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Up to 30 days after final dose of study intervention

  • Number of participants with Serious Adverse Events (SAEs)

    Up to 30 days after final dose of study intervention

  • Number of participants with Adverse Events of Special Interest (AESIs)

    Up to 30 days after final dose of study intervention

  • Number of participants with AEs leading to discontinuation

    Up to 30 days after final dose of study intervention

  • Number of participants with vital signs abnormalities

    Up to 30 days after final dose of study intervention

  • +8 more secondary outcomes

Study Arms (3)

Part 1

EXPERIMENTAL
Drug: Xanomeline/Trospium Chloride CapsuleDrug: Xanomeline Enteric CapsuleDrug: Trospium Chloride

Part 2

EXPERIMENTAL
Drug: Xanomeline/Trospium Chloride CapsuleDrug: Xanomeline Enteric CapsuleDrug: Trospium Chloride

Part 3

EXPERIMENTAL
Drug: Xanomeline/Trospium Chloride CapsuleDrug: Xanomeline Enteric Capsule

Interventions

Xanomeline/Trospium Chloride CapsuleDRUG

Specified dose on specified days

Also known as: BMS-986510, KarXT
Part 1Part 2Part 3
Xanomeline Enteric CapsuleDRUG

Specified dose on specified days

Also known as: BMS-986519, KarX-EC
Part 1Part 2Part 3
Trospium ChlorideDRUG

Specified dose on specified days

Also known as: BMS-986520, KarT
Part 1Part 2

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI between 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quotient Sciences

Nottingham, Nottinghamshire, NG1 6JS, United Kingdom

RECRUITING

Related Links

MeSH Terms

Interventions

xanomelinetrospium chloride

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

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

CONTACT

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2025

First Posted

July 14, 2025

Study Start

June 27, 2025

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

December 19, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
See Plan Description
Access Criteria
See Plan Description
More information

Locations

GB(1)