Recruiting
Phase 1

KarXT

Sponsor:

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Code:

NCT07204418

Conditions

Healthy Volunteers

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Xanomeline/ Trospium Chloride

Study Details

Brief summary:

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.

Conditions

Healthy Volunteers

Study ID

NCT07204418

Start date

Oct 13, 2025

Status verified date

Oct, 2026

Completion date

Dec 3, 2026

Anticipated

Primary completion date

Dec 3, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

56 participants

Anticipated

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: KarXT

Interventions

Xanomeline/ Trospium Chloride

Specified dose on specified days

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

Locations

ICON - Lenexa

Recruiting

Lenexa, Kansas, United States, 66219-9746

Contacts

Patrick Yao, Site 0002

913-410-2674

More Information

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Healthy volunteer
  • Pharmacokinetics
  • BMS-986510
  • KarXT
  • Cobenfy
  • CYP2D6

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Karuna Therapeutics, Inc., a Bristol Myers Squibb company on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.