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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

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

Who can join

Ages 18 to 65 · All sexes · Healthy volunteers welcome

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.

About the study

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.

What is being tested

• Xanomeline/ Trospium Chloride (drug)

Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Participants: 56 · Started: Oct 13, 2025

Contact the study team

• BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286

Official record on ClinicalTrials.gov — NCT07204418

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.