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NCT Number: NCT07063342

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

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.

Recruiting

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences

Nottingham, Nottinghamshire, NG1 6JS, United Kingdom

Location status: Recruiting

Location contact

Philip Evans, Site 0001

CONTACT

4401159749000

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Xanomeline/Trospium Chloride Capsule

Drug

Specified dose on specified days

Other names: BMS-986510, KarXT

Xanomeline Enteric Capsule

Drug

Specified dose on specified days

Other names: BMS-986519, KarX-EC

Trospium Chloride

Drug

Specified dose on specified days

Other names: BMS-986520, KarT

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to Day 23

  2. Time of maximum observed concentration (Tmax)

    Time frame: Up to Day 23

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

    Time frame: Up to Day 23

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

    Time frame: Up to Day 23

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

    Time frame: Up to Day 23

  6. Concentration at the end of a dosing interval (Ctau)

    Time frame: Up to Day 23

  7. Apparent total body clearance (CLT/F)

    Time frame: Up to Day 23

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

    Time frame: Up to Day 23

Secondary outcomes

  1. Number of participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 30 days after final dose of study intervention

  2. Number of participants with Serious Adverse Events (SAEs)

    Time frame: Up to 30 days after final dose of study intervention

  3. Number of participants with Adverse Events of Special Interest (AESIs)

    Time frame: Up to 30 days after final dose of study intervention

  4. Number of participants with AEs leading to discontinuation

    Time frame: Up to 30 days after final dose of study intervention

  5. Number of participants with vital signs abnormalities

    Time frame: Up to 30 days after final dose of study intervention

  6. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 30 days after final dose of study intervention

  7. Number of participants with physical examination abnormalities

    Time frame: Up to 30 days after final dose of study intervention

  8. Number of participants with clinical laboratory abnormalities

    Time frame: Up to 30 days after final dose of study intervention

  9. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Time frame: Up to Day 25

  10. Geometric mean ratio of Cmax

    Time frame: Up to Day 23

  11. Geometric mean ratio of AUC(0-T)

    Time frame: Up to Day 23

  12. Geometric mean ratio of AUC(INF)

    Time frame: Up to Day 23

  13. Geometric mean ratio of area under the concentration-time curve in 1 dosing interval (AUC(TAU))

    Time frame: Up to Day 23

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

Phase 1, 3-Part, Open-label Study to Evaluate the Pharmacokinetics of Novel KarX (BMS-986519) and KarT (BMS-986520) Prototypes Versus the KarXT (BMS-986510) and KarX-EC (BMS-986519) Reference Following Single Doses, and to Explore the Effect of Food After Multiple Doses of Selected Prototypes in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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