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NCT07204418PHASE1RecruitingAccepts Healthy Volunteers

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

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Start Date

10/13/2025

Completion Date

12/3/2026

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.

Eligibility Criteria

Age Range: 18 years to 65 years

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.

Interventions

DRUG

Xanomeline/ Trospium Chloride

Interested in This Trial?

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Conditions

Healthy Volunteers

Locations

Anaheim Clinical Trials

Anaheim, California 92801

United States

ICON - Lenexa

Lenexa, Kansas 66219-9746

United States

ICON Development Solutions

San Antonio, Texas 78209

United States