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
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07257120
Related Trials
Neurobiology of Suicide
NCT025439831 location
Effects of Sucralose on Drug Absorption and Metabolism (The SweetMeds Study)
NCT034070791 location
Suvorexant for Alcohol Use Disorder (AUD): Neural Mechanisms
NCT064840751 location
A Study to Evaluate BMS-986470 in Healthy Volunteers and Participants With Sickle Cell Disease
NCT0648130634 locations
Collection of Tissue Specimens From Patients With Solid Tumors or Blood Disorders and Their HLA-Compatible Family Members
NCT000710451 location