Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-02-22 @ 4:15 PM
Study NCT ID:
NCT01765868
Status:
COMPLETED
Last Update Posted:
2023-08-08
First Post:
2012-12-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-07', 'studyFirstSubmitDate': '2012-12-28', 'studyFirstSubmitQcDate': '2013-01-08', 'lastUpdatePostDateStruct': {'date': '2023-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent of orally absorbed dose', 'timeFrame': 'over 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Betrixaban', 'Healthy', 'Bioavailability'], 'conditions': ['Healthy Subjects']}, 'descriptionModule': {'briefSummary': 'This is a open label, single center, single oral dose, study of PRT054021, in healthy subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult men ages of 19 and 65 years old, inclusive\n* BMI of 18-35 kg/m2\n\nExclusion Criteria:\n\n* Clinically significant comorbid disease\n* History of substance abuse'}, 'identificationModule': {'nctId': 'NCT01765868', 'briefTitle': 'A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alexion Pharmaceuticals, Inc.'}, 'officialTitle': 'A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers.', 'orgStudyIdInfo': {'id': '07-012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Arm Oral and IV Betrixaban', 'interventionNames': ['Drug: Betrixaban']}], 'interventions': [{'name': 'Betrixaban', 'type': 'DRUG', 'description': 'Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose', 'armGroupLabels': ['Single Arm Oral and IV Betrixaban']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Portola Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}