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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Xanomeline/trospium chloride

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: First line of the email MUST contain NCT # and Site #.
• Study Contact Backup: Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com

Study Locations

• United States
  • Nevada
    • Las Vegas, Nevada, United States, 89113-2246
      • Recruiting
      • PPD | Las Vegas Clinical Research Unit
      • Contact: Shawn Searle, Site 0001; Phone Number: 877-773-3707

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 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 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.
• Other protocol defined inclusion/exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KarXT	Drug: Xanomeline/trospium chloride; Specified dose on specified days; Other Names: KarXT; BMS-986510

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed concentration (Cmax) of KarXT in Milk		Up to Day 7
Time of maximum observed concentration (Tmax) of KarXT in Milk		Up to Day 7
Area under the concentration-time curve from time zero to 12 hours post morning dose [AUC(0-12)] of KarXT in Milk		Up to Day 7
Area under the concentration-time curve from time zero to 24 hours post morning dose [AUC(0-24)] of KarXT in Milk		Up to Day 7
Average concentration (Cavg) of KarXT in Milk		Up to Day 7
Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]		Up to Day 7
Total amount of KarXT recovered in milk (AR)		Up to Day 7
Milk-plasma ratio of KarXT (M/P)	Calculated as milk AUC(0-12)/plasma AUC(0-12)	Up to Day 7

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of KarXT in plasma	Up to Day 7
Tmax of KarXT in plasma	Up to Day 7
AUC (0-12) of KarXT in plasma	Up to Day 7
AUC (0-24) of KarXT in plasma	Up to Day 7
Cavg of KarXT in plasma	Up to Day 7
Estimated daily infant dosage of KarXT	Up to Day 7
Relative infant dosage of KarXT	Up to Day 7
Number of participants with Adverse Events (AEs)	Up to Day 34
Number of participants with Serious Adverse Events (SAEs)	Up to Day 34
Number of participants with physical examination abnormalities	Up to Day 7
Number of participants with vital signs abnormalities	Up to Day 7
Number of participants with 12-Lead electrocardiogram (ECG) abnormalities	Up to Day 7
Number of participants with clinical laboratory abnormalities	Up to Day 7
Columbia-Suicide Severity Rating Scale (C-SSRS)	Up to Day 7
Number of participants with Adverse Events of Special Interest (AESIs)	Up to Day 34

Collaborators and Investigators

• Sponsor: Karuna Therapeutics
• Collaborators: Karuna Therapeutics, Inc., a Bristol Myers Squibb company
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): January 9, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: November 21, 2025
• First Submitted That Met QC Criteria: November 21, 2025
• First Posted (Actual): December 2, 2025

Study Record Updates

• Last Update Posted (Actual): February 18, 2026
• Last Update Submitted That Met QC Criteria: February 13, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Pharmacokinetics; Healthy volunteer; Healthy lactating women; BMS-986510; KarXT; Cobenfy
• Additional Relevant MeSH Terms: xanomeline; trospium chloride
• Other Study ID Numbers: CN012-0067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No