KarXT levels in breast milk and blood of lactating people
A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
This trial will measure how much of KarXT's ingredients (xanomeline and trospium) appear in the breast milk and blood of healthy breastfeeding women after taking the medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Karuna Therapeutics, Inc., a Bristol Myers Squibb company Industry-sponsored |
| Locations | 1 site (Las Vegas, Nevada) |
| Trial ID | NCT07257120 on ClinicalTrials.gov |
What this trial studies
This Phase 4 pharmacokinetic study gives multiple oral doses of KarXT to healthy lactating participants and collects timed plasma and breast milk samples to quantify xanomeline and trospium concentrations. Participants must have established lactation (at least 4 weeks postpartum), meet BMI and weight criteria, and be able to produce a stable milk volume by pumping. Subjects agree to exclusively pump during treatment and to refrain from breastfeeding or providing milk to an infant until after the specified post-dose withholding period. Dosing and serial sample collection are conducted at the PPD Las Vegas Clinical Research Unit under sponsorship of Karuna Therapeutics (a Bristol Myers Squibb company).
Who should consider this trial
Good fit: Healthy lactating females at least four weeks postpartum who meet BMI/weight criteria, can produce stable milk by pumping, and are willing to exclusively pump and withhold breastfeeding per protocol.
Not a fit: People who are not lactating, cannot pump exclusively, must continue direct breastfeeding during the study period, or have excluded organ dysfunction are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could help clinicians and nursing parents understand KarXT exposure during breastfeeding and inform safer breastfeeding recommendations.
How similar studies have performed: There are limited prior data specifically on KarXT in human milk; lactation pharmacokinetic studies of other small-molecule drugs have been done, but this application is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Las Vegas, Nevada
- PPD | Las Vegas Clinical Research Unit — Las Vegas, Nevada, United States (Recruiting)
Study contacts
- Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.