Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 10:58 PM
Study NCT ID:
NCT06911567
Status:
COMPLETED
Last Update Posted:
2025-07-16
First Post:
2025-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess New Formulations of TEV-56286
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-15', 'studyFirstSubmitDate': '2025-03-28', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-07-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Drug Concentration (Cmax)', 'timeFrame': 'Up to Day 17'}, {'measure': 'Area Under the Drug Concentration-Time Curve from Time 0 to Last Measurable Drug Concentration [AUC(0-t)]', 'timeFrame': 'Up to Day 17'}, {'measure': 'Area Under the Drug Concentration-Time Curve from Time 0 to Infinity [AUC(0-inf)]', 'timeFrame': 'Up to Day 17'}], 'secondaryOutcomes': [{'measure': 'Number of participants with at least one treatment-emergent adverse event', 'timeFrame': 'Up to Day 26'}, {'measure': 'Number of participants who did not complete the trial due to an adverse event', 'timeFrame': 'Up to Day 26'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the relative bioavailability of TEV-56286 test formulations compared to TEV-56286 reference product in healthy adult participants.\n\nThe secondary objective is to evaluate the safety and tolerability of TEV-56286.\n\nThe planned duration for each participant is approximately 70 days which includes a 45 day screening period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) between 18.5 kg/m2 to 32.0 kg/m2 (inclusive)\n* Females of childbearing potential agree to take appropriate measures to prevent pregnancy during the study\n* Males who do not have a documented vasectomy or are not congenitally sterile must agree to abstinence or use of barrier method with spermicide with female partner. Male participant who is having sexual intercourse with a woman of childbearing potential who is not currently pregnant will be advised of her requirement to use an additional highly effective contraceptive method\n* NOTE - Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* Participation in another clinical trial simultaneously\n* Females who are lactating, breastfeeding, or intends to become pregnant over the course of the study\n* History of alcohol, drug or any other substance, abuse, addiction or dependence in the last 12 months (except for caffeine)\n* Major trauma or surgery in the 2 months before screening or at any time between screening and the first dose of IMP, or surgery scheduled during the study or follow-up period\n* Donated blood or blood products (eg, white blood cells \\[WBCs\\], platelets, etc.) within the 60 days before screening, or has donated blood or blood products at least twice within the 6 months before screening, or has donated plasma within 7 days of the screening visit or has received blood or blood products in the 6 weeks before screening\n* Personal or family history of arrhythmia, sudden unexplained death at a young age (before 40 years) in a first-degree relative, or long QT syndrome, or a personal history of syncope, or previous personal treatment for high blood pressure\n* NOTE - Additional criteria apply, please contact the investigator for more information'}, 'identificationModule': {'nctId': 'NCT06911567', 'briefTitle': 'A Study to Assess New Formulations of TEV-56286', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'An Open-Label, Randomized, Crossover Study to Assess the Comparative Bioavailability of New TEV-56286 Formulations Compared to a Reference TEV-56286 Capsule Formulation Following Single-Dose Administration in Healthy Participants', 'orgStudyIdInfo': {'id': 'TV56286-BA-10218'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Random sequence of test and reference formulations', 'interventionNames': ['Drug: TEV-56286 Test', 'Drug: TEV-56286 Reference']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Random sequence of test and reference formulations', 'interventionNames': ['Drug: TEV-56286 Test', 'Drug: TEV-56286 Reference']}], 'interventions': [{'name': 'TEV-56286 Test', 'type': 'DRUG', 'otherNames': ['Emrusolmin'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}, {'name': 'TEV-56286 Reference', 'type': 'DRUG', 'otherNames': ['Emrusolmin'], 'description': 'Administered orally', 'armGroupLabels': ['Cohort 1', 'Cohort 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33025', 'city': 'Miramar', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 12141', 'geoPoint': {'lat': 25.98731, 'lon': -80.23227}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D LLC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please visit www.clinicalstudydatarequest.com to make your request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}