RecruitingPhase 4NCT07257120

KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Enrollment

8 participants

Start Date

Jan 9, 2026

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteers

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

Participants should have a body mass index (BMI) of 18.0 kg/m2 to 35.0 kg/m2, inclusive, and body weight ≥ 50 kg (110 lb), at screening.
Participants should have well-established lactation (ie, at least 4 weeks postpartum) and can produce stable milk product (ie, approximately 3 oz per 3 hours at screening) using the methods required for the study.
Participants should be willing to exclusively pump breast milk throughout the treatment period and during the 24-hour post last dose period of milk collection during the CRU domincile period.
Participants should agree not to breastfeed or provide milk to infant until after 96 hours post last dose.

Exclusion Criteria2

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 as assessed by the investigator.
Participants must not have history or presence of clinically significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (eg, obstructive disorders \[including conditions that may decrease GI motility, such as ulcerative colitis, intestinal atony, and myasthenia gravis\]), endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the investigator, would jeopardize the safety of the participant or the validity of the study results.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGXanomeline/trospium chloride

Specified dose on specified days

Locations(1)

PPD | Las Vegas Clinical Research Unit

Las Vegas, Nevada, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07257120

Related Trials

Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members

NCT000710451 location