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NCT Number: NCT07204418

A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

The purpose of this study is to evaluate the pharmacokinetics (PK) of xanomeline following administration of KarXT in CYP2D6 normal/extensive, intermediate, poor, and ultrarapid metabolizers.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participant must be healthy male and female (INOCBP) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs (VS), and clinical laboratory determinations.
  • Participant must be a normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizer.
  • Participant must have body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.

Exclusion criteria

  • Participants must not have evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population reference ranges.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Treatment and study plan

Xanomeline/ Trospium Chloride

Drug

Specified dose on specified days

Other names: BMS-986510, KarXT

Primary outcomes

  1. Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))

    Time frame: Up to Day 17

Secondary outcomes

  1. Number of participants with Adverse Events (AEs)

    Time frame: Up to 28 days post last dose

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

    Time frame: Up to 28 days post last dose

  3. Number of participants with physical examination abnormalities

    Time frame: Up to 28 days post last dose

  4. Number of participants with vital sign abnormalities

    Time frame: Up to 28 days post last dose

  5. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 28 days post last dose

  6. Number of participants with clinical laboratory test abnormalities

    Time frame: Up to 28 days post last dose

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

    Time frame: Up to 28 days post last dose

  8. Number of participants with AEs of Special Interest (AESIs)

    Time frame: Up to 28 days post last dose

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 the NCT# and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Industry

Registry information

Official study title

A Phase 1, 4-part, Open-label Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Oct 2, 2025
Registry last updated
Feb 19, 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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