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Clinical Trials in the USA / NCT07204418
Recruiting Phase 1

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

NCT07204418 · tracked via the Priya Life Science USA tracker
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Phase
Phase 1
Started
2025-10-13
Last updated
2026-10-13

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

Xanomeline/ Trospium Chloride →

Xanomeline/ Trospium Chloride: Specified dose on specified days

Study 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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • 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

Trial sites (3)

FacilityCityRegionStatus
Local Institution - 0003 Anaheim California Completed
ICON - Lenexa Lenexa Kansas Recruiting
Local Institution - 0001 San Antonio Texas Completed

More Karuna Therapeutics, Inc., a Bristol Myers Squibb company trials in the USA

A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-1) Recruiting
Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3) Recruiting
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents Recruiting
A Study to Evaluate KarXT as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-4) Recruiting
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07204418 on ClinicalTrials.gov ↗ ← All trials in the USA