Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT07257120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
KarXT Concentrations in the Breast Milk and Plasma of Lactating Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C075257', 'term': 'xanomeline'}, {'id': 'C003330', 'term': 'trospium chloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed concentration (Cmax) of KarXT in Milk', 'timeFrame': 'Up to Day 7'}, {'measure': 'Time of maximum observed concentration (Tmax) of KarXT in Milk', 'timeFrame': 'Up to Day 7'}, {'measure': 'Area under the concentration-time curve from time zero to 12 hours post morning dose [AUC(0-12)] of KarXT in Milk', 'timeFrame': 'Up to Day 7'}, {'measure': 'Area under the concentration-time curve from time zero to 24 hours post morning dose [AUC(0-24)] of KarXT in Milk', 'timeFrame': 'Up to Day 7'}, {'measure': 'Average concentration (Cavg) of KarXT in Milk', 'timeFrame': 'Up to Day 7'}, {'measure': 'Amount of KarXT recovered in milk within 12 hours of dosing [AR(12)]', 'timeFrame': 'Up to Day 7'}, {'measure': 'Total amount of KarXT recovered in milk (AR)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Milk-plasma ratio of KarXT (M/P)', 'timeFrame': 'Up to Day 7', 'description': 'Calculated as milk AUC(0-12)/plasma AUC(0-12)'}], 'secondaryOutcomes': [{'measure': 'Cmax of KarXT in plasma', 'timeFrame': 'Up to Day 7'}, {'measure': 'Tmax of KarXT in plasma', 'timeFrame': 'Up to Day 7'}, {'measure': 'AUC (0-12) of KarXT in plasma', 'timeFrame': 'Up to Day 7'}, {'measure': 'AUC (0-24) of KarXT in plasma', 'timeFrame': 'Up to Day 7'}, {'measure': 'Cavg of KarXT in plasma', 'timeFrame': 'Up to Day 7'}, {'measure': 'Estimated daily infant dosage of KarXT', 'timeFrame': 'Up to Day 7'}, {'measure': 'Relative infant dosage of KarXT', 'timeFrame': 'Up to Day 7'}, {'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to Day 34'}, {'measure': 'Number of participants with Serious Adverse Events (SAEs)', 'timeFrame': 'Up to Day 34'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to Day 7'}, {'measure': 'Number of participants with vital signs abnormalities', 'timeFrame': 'Up to Day 7'}, {'measure': 'Number of participants with 12-Lead electrocardiogram (ECG) abnormalities', 'timeFrame': 'Up to Day 7'}, {'measure': 'Number of participants with clinical laboratory abnormalities', 'timeFrame': 'Up to Day 7'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'Up to Day 7'}, {'measure': 'Number of participants with Adverse Events of Special Interest (AESIs)', 'timeFrame': 'Up to Day 34'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteer', 'Pharmacokinetics', 'BMS-986510', 'KarXT', 'Cobenfy', 'Healthy lactating women'], 'conditions': ['Healthy Volunteers']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.BMSClinicalTrials.com', 'label': 'BMS Clinical Trial Patient Recruiting'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* 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.\n* 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.\n* Participants should agree not to breastfeed or provide milk to infant until after 96 hours post last dose.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* Other protocol defined inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT07257120', 'briefTitle': 'KarXT Concentrations in the Breast Milk and Plasma of Lactating Females', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karuna Therapeutics'}, 'officialTitle': 'A Phase IV, Open-label, Single-group Study Evaluating KarXT Concentrations in the Breast Milk and Plasma of Healthy Lactating Female Participants', 'orgStudyIdInfo': {'id': 'CN012-0067'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KarXT', 'interventionNames': ['Drug: Xanomeline/trospium chloride']}], 'interventions': [{'name': 'Xanomeline/trospium chloride', 'type': 'DRUG', 'otherNames': ['KarXT', 'BMS-986510'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['KarXT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89113-2246', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'contacts': [{'name': 'Site 0001', 'role': 'CONTACT'}], 'facility': 'Local Institution - 0001', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}], 'centralContacts': [{'name': 'BMS Clinical Trials Contact Center www.BMSClinicalTrials.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '8559073286'}, {'name': 'First line of the email MUST contain the NCT# and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'See plan description', 'ipdSharing': 'YES', 'description': "BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.\n\nAdditional information regarding Bristol Myers Squibb's data sharing policy and process can be found at:\n\nhttps://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html", 'accessCriteria': 'See plan description'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karuna Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}