Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2026-01-24 @ 10:01 PM
Study NCT ID:
NCT06605950
Status:
COMPLETED
Last Update Posted:
2025-07-04
First Post:
2024-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C075257', 'term': 'xanomeline'}, {'id': 'C003330', 'term': 'trospium chloride'}, {'id': 'D009853', 'term': 'Omeprazole'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Part 1 of this study is double-blind while Part 2 is open-label.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2024-09-18', 'studyFirstSubmitQcDate': '2024-09-18', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Adverse Events (AEs)', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Number of participants with Serioues AEs (SAEs)', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Body weight', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Number of participants with 12-lead electrocardiogram abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Number of participants with clinical laboratory assessment abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 1'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'On Day 30', 'description': 'Part 1'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Time of maximum observed plasma concentration (Tmax)', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Area under the concentration-time curve in 1 dosing interval (AUC(TAU))', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 24 hours (AUC(0-24))', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Apparent total body clearance (CLT/F)', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}, {'measure': 'Terminal elimination half-life (T-HALF)', 'timeFrame': 'Up to Day 29', 'description': 'Part 2'}], 'secondaryOutcomes': [{'measure': 'Cmax', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'Tmax', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'AUC(0-24)', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'AUC(TAU)', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'CLT/F', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'Vz/F', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'T-HALF', 'timeFrame': 'Up to Day 29', 'description': 'Part 1'}, {'measure': 'Number of participants with AEs', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Number of participants with SAEs', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Number of participants with vital sign abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Body weight', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Number of participants with 12-lead electrocardiogram abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Number of participants with physical examination abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'Number of participants with clinical laboratory assessment abnormalities', 'timeFrame': 'Up to 28 days post last dose', 'description': 'Part 2'}, {'measure': 'C-SSRS', 'timeFrame': 'On Day 30', 'description': 'Part 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Japanese', 'Elderly', 'Adult', 'Healthy', 'Pharmacokinetics', 'BMS-986510', 'BMS-986519', 'KarXT', 'Omeprazole', 'Drug interaction'], '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 assess the safety, tolerability, and pharmacokinetics (PK) of multiple doses of KarXT + KarX-EC capsules versus KarXT capsules in healthy adult and elderly participants of Japanese ethnicity and to assess the effect of multiple doses of omeprazole on the exposure of xanomeline and trospium administered as KarXT + KarX-EC capsules in healthy adult participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria\n\n* Inclusion Criteria for Healthy Adult Japanese Participants (Group A):.\n* Healthy adult participants must be 19 to 55 years of age, inclusive.\n\n i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.\n\nii) Must have a body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.\n\niii) Must have an estimated glomerular filtration rate (eGFR) of ≥ 90 mL/min/1.73m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation at the screening visit. One repeat measurement is allowed.\n\n* Inclusion Criteria for Healthy Elderly Japanese Participants (Groups B and C):.\n* Healthy elderly participants must be 56 to 90 years of age, inclusive.\n\n i) Both participant's biological parents are of ethnic Japanese ancestry. Participants must be first generation Japanese.\n\nii) Must have a BMI ≥ 18.0 and ≤ 35.0 kg/m2 (inclusive), at the time of signing the ICF.\n\niii) Must have an eGFR of \\> 60 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.\n\n* Inclusion Criteria for Healthy Adult Participants (Groups D):.\n* Healthy adult participants must be 19 to 55 years of age, inclusive.\n\n i) Participants with any ethnicity can be included.\n\nii) Must have a BMI of 18.0 to 32.0 kg/m2 (inclusive), at the time of signing the ICF.\n\niii) Must have an eGFR of ≥ 90 mL/min/1.73m2 by the CKD-EPI equation at the screening visit. One repeat measurement is allowed.\n\nExclusion Criteria\n\n\\- Exclusion Criteria for All Participants (Groups A, B, C, and D):.\n\ni) Participant is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n\nii) History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n\niii) Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.\n\niv) History of cancer that has not been in full remission for \\>5 years (except basal cell skin cancer or squamous cell skin cancer with history of curative treatment and no recurrence for \\> 1 year prior to the screening visit).\n\n* Other protocol-defined Inclusion/Exclusion criteria apply."}, 'identificationModule': {'nctId': 'NCT06605950', 'briefTitle': 'A Study to Assess the Safety, Tolerability and Pharmacokinetics (PK) of Xanomeline With Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity and to Assess the Effect of Omeprazole on the PK of Xanomeline With Trospium Chloride in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Karuna Therapeutics'}, 'officialTitle': 'A 2-Part, Phase 1, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of Multiple Doses of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride Versus KarXT in Healthy Adult and Elderly Participants of Japanese Ethnicity (Part 1) and an Open-label Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Dual-burst Release of Xanomeline With Immediate-Release Trospium Chloride in Healthy Adult Participants (Part 2)', 'orgStudyIdInfo': {'id': 'CN012-0030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'interventionNames': ['Drug: KarXT', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'interventionNames': ['Drug: KarXT', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'interventionNames': ['Drug: KarXT', 'Drug: KarX-EC', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group D', 'interventionNames': ['Drug: KarXT', 'Drug: KarX-EC', 'Drug: Omeprazole']}], 'interventions': [{'name': 'KarXT', 'type': 'DRUG', 'otherNames': ['BMS-986510', 'Xanomeline/Trospium Chloride'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group A', 'Group B', 'Group C', 'Group D']}, {'name': 'KarX-EC', 'type': 'DRUG', 'otherNames': ['BMS-986519', 'Xanomeline Enteric-coated'], 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group C', 'Group D']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group A', 'Group B', 'Group C']}, {'name': 'Omeprazole', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Group D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Cenexel ACT (Anaheim Clinical Trials)', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], '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 Myer 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'}}}}