Healthy VolunteersPhase 4NCT07257120
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
A Phase 4 study testing Xanomeline/trospium chloride in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Xanomeline/trospium chloride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2026to 8 Jun 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Local Institution - 0001
Las Vegas, Nevada, 89113-2246
About this study
Official title: A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
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
- Healthy Volunteers
- Being tested
- Xanomeline/trospium chloride
- Keywords
- Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Healthy lactating women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xanomeline/trospium chlorideDrug
Also called KarXT, BMS-986510
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| KarXT | Experimental | Not described Receives: Drug: Xanomeline/trospium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed concentration (Cmax) of KarXT in Milk
Measured: Up to Day 7
Time of maximum observed concentration (Tmax) of KarXT in Milk
Measured: 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
Measured: 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
Measured: Up to Day 7
Average concentration (Cavg) of KarXT in Milk
Measured: Up to Day 7
Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]
Measured: Up to Day 7
Total amount of KarXT recovered in milk (AR)
Measured: Up to Day 7
Milk-plasma ratio of KarXT (M/P)
Calculated as milk AUC(0-12)/plasma AUC(0-12)
Measured: Up to Day 7
Secondary outcomes (15)
Cmax of KarXT in plasma
Measured: Up to Day 7
Tmax of KarXT in plasma
Measured: Up to Day 7
AUC (0-12) of KarXT in plasma
Measured: Up to Day 7
AUC (0-24) of KarXT in plasma
Measured: Up to Day 7
Cavg of KarXT in plasma
Measured: Up to Day 7
Estimated daily infant dosage of KarXT
Measured: Up to Day 7
Relative infant dosage of KarXT
Measured: Up to Day 7
Number of participants with Adverse Events (AEs)
Measured: Up to Day 34
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to Day 34
Number of participants with physical examination abnormalities
Measured: Up to Day 7
Number of participants with vital signs abnormalities
Measured: Up to Day 7
Number of participants with 12-Lead electrocardiogram (ECG) abnormalities
Measured: Up to Day 7
Number of participants with clinical laboratory abnormalities
Measured: Up to Day 7
Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 7
Number of participants with Adverse Events of Special Interest (AESIs)
Measured: Up to Day 34
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start9 Jan 2026
- Primary completion8 Jun 2026
- Study completion8 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257120
- Sponsor's protocol ID
- CN012-0067
- Status last verified
- Jun 2026
- First submitted
- 21 Nov 2025
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants
- ClinicalTrials.gov ID
- NCT07257120
- Acronym / sponsor ID
- CN012-0067
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteer, Pharmacokinetics, BMS-986510, KarXT, Cobenfy, Healthy lactating women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Karuna Therapeutics, Inc., a Bristol Myers Squibb companyIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 8 Jun 2026 (actual)
- Study completion
- 8 Jun 2026 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KarXT | Experimental | Drug: Xanomeline/trospium chloride |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Xanomeline/trospium chlorideAlso: KarXT, BMS-986510Specified dose on specified days | Drug | KarXT |
Primary outcome
Maximum observed concentration (Cmax) of KarXT in Milk
Time frame: Up to Day 7
Time of maximum observed concentration (Tmax) of KarXT in Milk
Time frame: 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
Time frame: 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
Time frame: Up to Day 7
Average concentration (Cavg) of KarXT in Milk
Time frame: Up to Day 7
Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]
Time frame: Up to Day 7
Total amount of KarXT recovered in milk (AR)
Time frame: Up to Day 7
Milk-plasma ratio of KarXT (M/P)
Time frame: Up to Day 7
Calculated as milk AUC(0-12)/plasma AUC(0-12)
15 secondary outcomes
Cmax of KarXT in plasma
Time frame: Up to Day 7
Tmax of KarXT in plasma
Time frame: Up to Day 7
AUC (0-12) of KarXT in plasma
Time frame: Up to Day 7
AUC (0-24) of KarXT in plasma
Time frame: Up to Day 7
Cavg of KarXT in plasma
Time frame: Up to Day 7
Estimated daily infant dosage of KarXT
Time frame: Up to Day 7
Relative infant dosage of KarXT
Time frame: Up to Day 7
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 34
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 34
Number of participants with physical examination abnormalities
Time frame: Up to Day 7
Number of participants with vital signs abnormalities
Time frame: Up to Day 7
Number of participants with 12-Lead electrocardiogram (ECG) abnormalities
Time frame: Up to Day 7
Number of participants with clinical laboratory abnormalities
Time frame: Up to Day 7
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 7
Number of participants with Adverse Events of Special Interest (AESIs)
Time frame: Up to Day 34
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Xanomeline/trospium chloride in people with Healthy Volunteers, run by Karuna Therapeutics, Inc., a Bristol Myers Squibb company at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed concentration (Cmax) of KarXT in Milk (time frame: Up to Day 7). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.