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

Not Applicable

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: Xanomeline/ Trospium Chloride

• Registration Number: NCT07204418
• Lead Sponsor: Karuna Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-24
• Study First Submitted QC: 2025-09-24
• Last Update Submitted: 2025-09-24
• Study First Posted: 2025-10-02
• Last Update Posted: 2025-10-02
• Study Start: 2025-10-14
• Primary Completion: 2026-12-03
• Study Completion: 2026-12-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
KarXT	Xanomeline/ Trospium Chloride	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (3)

Local Institution - 0003; 🇺🇸 Anaheim, California, United States

Local Institution - 0002; 🇺🇸 Lenexa, Kansas, United States

Local Institution - 0001; 🇺🇸 San Antonio, Texas, United States