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KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

NCT07257120 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2026-02-18

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Xanomeline/trospium chloride

Specified dose on specified days

Sponsors & Collaborators

  • Karuna Therapeutics, Inc., a Bristol Myers Squibb company

    collaborator UNKNOWN

  • Karuna Therapeutics

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-09
Primary Completion
2027-11-30
Completion
2027-11-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07257120 on ClinicalTrials.gov