Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Not Yet Recruiting Study icon

Not Yet Recruiting

Trial ID CN012-0067  |   NCT07257120

KarXT Concentrations in the Breast Milk and Plasma of Lactating Females

Warning icon
Sorry, this study is not yet accepting participants.
Please bookmark this page to check back at a later date.  You may also click the “Check Your Eligibility” button and answer a few questions about your health to find out if you might be a match to another study.
Check Your Eligibility

Summary

  • Phase 4
  • Female Gender icon
  • 18+
    Age Range
  • 1
    Locations
  • BMS Not Yet Recruiting Study icon
    Not Yet Recruiting

Overview

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.

print Print
email Email

Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
:
  • 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.
    1. 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.
      1. 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.
        1. Participants should agree not to breastfeed or provide milk to infant until after 96 hours post last dose.

          Exclusion Criteria

          Exclusion Criteria Icon
          :
          • 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.
            1. 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.
              1. Other protocol defined inclusion/exclusion criteria apply.
                Additional Information *

                Treatment Options

                Study Arms

                ASSIGNED INTERVENTION

                Study Arms

                Experimental: KarXT

                ASSIGNED INTERVENTION
                Please check back later for a recruiting site or find another trial by clicking 'Check Your Eligibility'
                Check Your Eligibility
                Answer some questions about Your health to see if you may match to this trial
                Match to a Trial
                If you are a match, click on the study to see the list of study site locations.
                Select a Study Site Location
                Select a study site location that is convenient for you
                Register
                Provide your contact details for the study site to connect with you.

                Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you

                Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you