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Clinical Trial NCT07257120 for Healthy Volunteers is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Karuna Therapeutics, Inc., a Bristol Myers Squibb companyKarXT Concentrations in the Breast Milk and Plasma of Lactating Females Phase 4 8
Clinical Trial NCT07257120 is designed to study Treatment for Healthy Volunteers. It is a Phase 4 interventional study that is recruiting, having started on January 9, 2026, with plans to enroll 8 participants. Led by Karuna Therapeutics, Inc., a Bristol Myers Squibb company, it is expected to complete by November 30, 2027. The latest data from ClinicalTrials.gov was last updated on February 18, 2026.
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.
Official Title
A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
Conditions
Healthy VolunteersOther Study IDs
- CN012-0067
NCT ID Number
Start Date (Actual)
2026-01-09
Last Update Posted
2026-02-18
Completion Date (Estimated)
2027-11-30
Enrollment (Estimated)
8
Study Type
Interventional
PHASE
Phase 4
Status
Recruiting
Keywords
Healthy volunteer
Pharmacokinetics
BMS-986510
KarXT
Cobenfy
Healthy lactating women
Pharmacokinetics
BMS-986510
KarXT
Cobenfy
Healthy lactating women
Primary Purpose
Treatment
Design Allocation
Non-Randomized
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalKarXT | Xanomeline/trospium chloride Specified dose on specified days |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 | |
Estimated daily infant dosage of KarXT | Up to Day 7 | |
Relative infant dosage of KarXT | Up to Day 7 | |
Number of participants with Adverse Events (AEs) | Up to Day 34 | |
Number of participants with Serious Adverse Events (SAEs) | Up to Day 34 | |
Number of participants with physical examination abnormalities | Up to Day 7 | |
Number of participants with vital signs abnormalities | Up to Day 7 | |
Number of participants with 12-Lead electrocardiogram (ECG) abnormalities | Up to Day 7 | |
Number of participants with clinical laboratory abnormalities | Up to Day 7 | |
Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to Day 7 | |
Number of participants with Adverse Events of Special Interest (AESIs) | Up to Day 34 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
Accepts Healthy Volunteers
Yes
- 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.
- 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.
Karuna Therapeutics, Inc., a Bristol Myers Squibb company9 active studies to exploreStudy Central Contact
Contact: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com, 855-907-3286, [email protected]
Contact: First line of the email MUST contain NCT # and Site #.
1 Study Locations in 1 Countries
Nevada
PPD | Las Vegas Clinical Research Unit, Las Vegas, Nevada, 89113-2246, United States
Shawn Searle, Site 0001, Contact, 877-773-3707
Recruiting