Actively Recruiting
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Updated on 2026-02-18
8
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Body mass index (BMI) between 18.0 and 35.0 kg/m2 and body weight at least 50 kg (110 lb) at screening
- Well-established lactation of at least 4 weeks postpartum
- Ability to produce approximately 3 ounces of milk every 3 hours at screening
- Willingness to exclusively pump breast milk during treatment and 24 hours after last dose
- Agreement not to breastfeed or provide milk to infant until 96 hours after last dose
You will not qualify if you...
- Evidence of organ dysfunction or clinically significant abnormal physical exam, vital signs, ECG, or lab tests beyond target population ranges
- History or presence of significant cardiovascular, pulmonary, renal, hematologic, gastrointestinal (including certain obstructive disorders), endocrine, immunologic, dermatologic, neurologic, oncologic disease, or other conditions that could affect safety or study validity
- Other protocol-defined inclusion/exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
PPD | Las Vegas Clinical Research Unit
Las Vegas, Nevada, United States, 89113-2246
Actively Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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