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A Study to Evaluate the Effects of CYP2D6 Phenotypes on the Pharmacokinetics of Xanomeline Following KarXT Administration in Healthy Adult Participants Phase 1 56

Recruiting
Clinical Trial NCT07204418 is designed to study Treatment for Healthy Volunteers. It is a Phase 1 interventional study that is recruiting, having started on October 13, 2025, with plans to enroll 56 participants. Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company, it is expected to complete by December 3, 2026. The latest data from ClinicalTrials.gov was last updated on February 19, 2026.
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.
Official 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

Conditions
Healthy Volunteers
Other Study IDs
  • CN012-0012
NCT ID Number
NCT07204418
Start Date (Actual)
2025-10-13
Last Update Posted
2026-02-19
Completion Date (Estimated)
2026-12-03
Enrollment (Estimated)
56
Study Type
Interventional
PHASE
Phase 1
Status
Recruiting
Keywords
Healthy volunteer
Pharmacokinetics
BMS-986510
KarXT
Cobenfy
CYP2D6
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalKarXT
Xanomeline/ Trospium Chloride
Specified dose on specified days
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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 Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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
Number of participants with clinical laboratory test abnormalities
Up to 28 days post last dose
Columbia-Suicide Severity Rating Scale (C-SSRS)
Up to 28 days post last dose
Number of participants with AEs of Special Interest (AESIs)
Up to 28 days post last dose
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
  • 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.

  • 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.
Karuna Therapeutics, Inc., a Bristol Myers Squibb company logoKaruna Therapeutics, Inc., a Bristol Myers Squibb company9 active studies to explore
Study Central Contact
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain the NCT# and Site #.
3 Study Locations in 1 Countries

California

Anaheim Clinical Trials, Anaheim, California, 92801, United States
Peter Winkle, Site 0003, Contact, 949-295-7809
Recruiting

Kansas

ICON - Lenexa, Lenexa, Kansas, 66219-9746, United States
Patrick Yao, Site 0002, Contact, 913-410-2674
Recruiting

Texas

ICON Development Solutions, San Antonio, Texas, 78209, United States
Cassandra Key, Site 0001, Contact, 210-283-4552
Recruiting