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

Part of paid clinical trials in Anaheim, California.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT07204418
Phase
PHASE1
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Xanomeline/ Trospium Chloride — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Oct 13, 2025
Status verified
Feb 2026
Primary completion
Dec 3, 2026
Completion
Dec 3, 2026

Study Design

Enrollment
56 participants (estimated)
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT

Primary Outcome Measure

Geometric mean ratio for the area under the concentration-time curve from time zero to 12 hours post morning dose (AUC(0-12)) [ Time Frame: Up to Day 17 ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
    [email protected]
  • First line of the email MUST contain the NCT# and Site #.

Locations (3)

FacilityCityStateZIPSite coordinators
Anaheim Clinical TrialsAnaheimCalifornia92801
Peter Winkle, Site 0003
949-295-7809
ICON - LenexaLenexaKansas66219-9746
Patrick Yao, Site 0002
913-410-2674
ICON Development SolutionsSan AntonioTexas78209
Cassandra Key, Site 0001
210-283-4552

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Anaheim Clinical Trials· Anaheim, CAICON - Lenexa· Lenexa, KSICON Development Solutions· San Antonio, TX

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