Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-01-13 @ 7:50 AM
Study NCT ID:
NCT02596100
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2015-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C543086', 'term': 'betrixaban'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2015-10-21', 'studyFirstSubmitQcDate': '2015-11-02', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bioequivalence analysis using total area under the curve (Total AUC) after a single dose of Betrixaban in healthy subjects', 'timeFrame': '120 hours'}, {'measure': 'Bioequivalance analysis using peak concentration in plasma (Cmax) after a single dose of Betrixaban in healthy volunteers', 'timeFrame': '120 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bioequivalence'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is a single center open label randomized 4-period 2-sequence replicated crossover design study. A total of 52 healthy subjects will be randomized.', 'detailedDescription': 'Serial blood samples will be obtained for PK evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All inclusion criteria must be satisfied within 30 days of enrollment and must be documented in the source documents.\n* A healthy man or woman between the ages of 18 and 60\n* Has no clinically significant findings in medical history, physical examination, EKG and vital signs\n* Weighs \\> 45 kg (99 lbs.) and has body mass index (BMI) \\< 30 kg/m2\n* Agrees to abstain from alcohol consumption for 48 hrs prior to dosing and for the duration of each of the study in-house periods\n* Is a non-smoker or light smoker (no more than the equivalent of five cigarettes per day) and agrees to abstain from smoking for the duration of each of the study in-house periods\n\nExclusion Criteria:\n\n* None of the exclusion criteria may be present for enrollment\n* Known history (including family history) or symptoms of any clinically significant bleeding (i.e. a bleeding that required medical attention) or a vascular malformation\n* Major surgery, severe trauma or bone fracture within 3 months of the first dose of the study drug or a planned surgery within 1 month after the last dose of the study drug\n* History of blood donation of more than 500 mL within 3 months prior to the first dose of the study drug\n* History of alcohol abuse (greater than 3 alcoholic beverages per day)\n* Positive screen for drugs of abuse\n* Positive serology test for HIV, Hepatitis B or C\n* Has any allergy or sensitivity to fXa inhibitors'}, 'identificationModule': {'nctId': 'NCT02596100', 'briefTitle': 'A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations', 'orgStudyIdInfo': {'id': '15-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tablet', 'description': '80mg immediate release tablet', 'interventionNames': ['Drug: Betrixaban']}, {'type': 'EXPERIMENTAL', 'label': 'Capsule', 'description': '80mg immediate release capsule', 'interventionNames': ['Drug: Betrixaban']}], 'interventions': [{'name': 'Betrixaban', 'type': 'DRUG', 'armGroupLabels': ['Capsule', 'Tablet']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}