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RecruitingAccepts healthy volunteersPhase 1

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 · NCT07204418

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Phase 1
Target enrollment
56
US sites recruiting
1
Study start
October 13, 2025
Record last updated
October 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Xanomeline/ Trospium Chloride

Conditions: Healthy Volunteers

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • ICON - Lenexa

    Lenexa, KS 66219-9746

    Site contact: Patrick Yao, Site 0002 · 913-410-2674

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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A Study to Evaluate the Effects of CYP2D6 Phenotypes on the… (NCT07204418) | Bored Studies