KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Study ID
NCT07257120
Phase
PHASE4
Status
Recruiting
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Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Xanomeline/trospium chloride — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to characterize the PK of xanomeline and trospium in breast milk and plasma in healthy lactating female participants, following multiple oral administration of KarXT in healthy lactating participants.

Key Dates

Start date
Jan 9, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
8 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: KarXT

Primary Outcome Measure

Maximum observed concentration (Cmax) of KarXT in Milk [ Time Frame: Up to Day 7 ]

Central Contacts

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

Locations (1)

FacilityCityStateZIPSite coordinators
PPD | Las Vegas Clinical Research UnitLas VegasNevada89113-2246
Shawn Searle, Site 0001
877-773-3707

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By research site
PPD | Las Vegas Clinical Research Unit· Las Vegas, NV

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