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

NCT07204418 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CN012-0012
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

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))

  Up to Day 17

Secondary Outcomes (8)

• Number of participants with Adverse Events (AEs)

  Up to 28 days post last dose

• Number of participants with Serious Adverse Events (SAEs)

  Up to 28 days post last dose

• Number of participants with physical examination abnormalities

  Up to 28 days post last dose

• Number of participants with vital sign abnormalities

  Up to 28 days post last dose

• Number of participants with electrocardiogram (ECG) abnormalities

  Up to 28 days post last dose

Study Arms (1)

KarXT

EXPERIMENTAL

Drug: Xanomeline/ Trospium Chloride

Interventions

Xanomeline/ Trospium Chloride DRUG

Specified dose on specified days

Also known as: BMS-986510, KarXT

KarXT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karuna Therapeutics, Inc., a Bristol Myers Squibb company: lead

Study Sites (3)

Anaheim Clinical Trials

Anaheim, California, 92801, United States

RECRUITING

ICON - Lenexa

Lenexa, Kansas, 66219-9746, United States

RECRUITING

ICON Development Solutions

San Antonio, Texas, 78209, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

xanomeline; trospium chloride

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

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

CONTACT

Study Design

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

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: October 2, 2025
• Study Start: October 13, 2025
• Primary Completion (Estimated): December 3, 2026
• Study Completion (Estimated): December 3, 2026
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (3)