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Study of Xanomeline/Trospium Chloride in Healthy Adults

This study is looking at how your body processes Xanomeline/Trospium Chloride (KarXT), a combination drug. Specifically, it's investigating how different CYP2D6 metabolizer types (how your body breaks down certain medicines) affect the drug's levels in your blood. We're looking for 56 healthy adults, aged 18 to 65, who are either normal/extensive, intermediate, poor, or ultrarapid CYP2D6 metabolizers. The main goal is to measure the drug levels in your blood up to 12 hours after a morning dose, for up to 17 days. The study's current status is unclear.

Study design
This is an interventional study involving approximately 56 healthy adult participants. It aims to understand how different genetic profiles affect drug processing.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Drug levels will be measured for up to 12 hours after a morning dose, for up to 17 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07204418

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
~56 participants
Updated 2026-02-19 on ClinicalTrials.gov
What's tested:Xanomeline/ Trospium Chloride

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12))
Measured over Up to Day 17

Conditions

Healthy Volunteers

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Healthy VolunteersCYP2D6 Gene

NCT07204418

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Anaheim Clinical Trials

    Anaheim, Californiastudy coordinator listed

    Recruiting

  • ICON - Lenexa

    Lenexa, Kansasstudy coordinator listed

    Recruiting

  • ICON Development Solutions

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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