KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

NCT07257120 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CN012-0067
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Healthy volunteer; Pharmacokinetics; BMS-986510; KarXT; Cobenfy; Healthy lactating women

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (15)

• 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

Study Arms (1)

KarXT

EXPERIMENTAL

Drug: Xanomeline/trospium chloride

Interventions

Xanomeline/trospium chloride DRUG

Specified dose on specified days

Also known as: KarXT, BMS-986510

KarXT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

PPD | Las Vegas Clinical Research Unit

Las Vegas, Nevada, 89113-2246, United States

RECRUITING

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Interventions

xanomeline; trospium chloride

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286; Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)