Gene type may change how KarXT works in your body

NCT ID NCT07204418

Knowledge-focused Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study looks at how different versions of a liver enzyme (CYP2D6) affect the breakdown of xanomeline, one part of the drug KarXT. About 56 healthy volunteers with four different metabolism types will take KarXT and have their blood tested. The goal is to see if people who process drugs quickly or slowly have different drug levels, which could guide future dosing recommendations.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: KarXT (xanomeline and trospium chloride)
What this could lead to: If successful, this study could help doctors personalize dosing of KarXT based on a person's genetic metabolism, improving safety and effectiveness for conditions like schizophrenia.
What could go wrong: This is an early Phase 1 study in healthy volunteers, not patients. It only measures drug levels and safety, not whether the drug works for any disease. Results may not apply to real-world patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 56 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy volunteers

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

3 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

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Gene type may change how KarXT works in your body

What the study statuses mean