Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2026-02-20 @ 6:45 PM
Study NCT ID:
NCT02101866
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2014-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013607', 'term': 'Tablets'}], 'ancestors': [{'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2014-04-01', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic exposure profile of a single dose of a vapendavir 300 mg tablet compared to the exposure profile following a single dose of two 132 mg vapendavir capsules', 'timeFrame': 'maximum up to 46 days', 'description': 'PK and statatistical analyses will be performed to determine the Primary Outcome Measure'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bioavailability Study', 'Aviragen Therapeutics, Inc.', 'Aviragen Therapeutics', 'Aviragen'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This Phase 1 study aims to determine the oral bioavailability of a single dose of a new vapendavir tablet formulation and compare it to that of the previous vapendavir capsule formulation. The safety of both drug products will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be male or female between 18 and 55 years of age (inclusive) with BMI between 18 and 30 kg/m2 (inclusive), and weight ≥50 kg at the time of screening\n* Capable of giving written informed consent\n* Subject is able to understand and comply with the protocol requirements, instructions and restrictions\n* Healthy on the basis of physical examination, medical history, medication usage, VS, ECGs, and clinical laboratory tests\n* Female subjects must be of non-childbearing potential\n* Male subjects must agree to use a double barrier method of birth control\n\nExclusion Criteria:\n\n* Positive results for Hepatitis B, Hepatitis C, or HIV\n* Frequent use of tobacco products, including cigarettes, cigars, chewing tobacco\n* A medical history of significant hematological, gastrointestinal, respiratory, renal, hepatic, cerebrovascular, immunologic, psychiatric or cardiovascular disease or event; Current or recent respiratory infection\n* Presence or history of significant allergy\n* Clinically significant abnormalities noted on ECG\n* Screening vital signs representing sustained elevated blood pressure\n* Presence of significant gastrointestinal abnormalities\n* Safety laboratory abnormalities noted at screening which are clinically significant\n* Current or defined history of abuse of alcohol or illicit drugs\n* A positive pregnancy test at screening\n* Poor vein access or fear of venipuncture or sight of blood'}, 'identificationModule': {'nctId': 'NCT02101866', 'briefTitle': 'A Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Formulations in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxart'}, 'officialTitle': 'A Randomized, Single-Center, Open-Label, Two-Period, Two-Sequence, Crossover, Comparative Study to Compare the Oral Bioavailability of Single Doses of Two Vapendavir Drug Product Formulations in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BTA798-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vapendavir 300 mg tablet', 'description': 'Vapendavir 300 mg tablet single dose with up to 7 day washout period followed by two vapendavir 132 mg capsules single dose', 'interventionNames': ['Drug: Vapendavir 300 mg tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Two Vapendavir 132 mg capsules', 'description': 'Two Vapendavir 132 mg capsules single dose with up to 7 day washout period followed by Vapendavir 300 mg tablet single dose', 'interventionNames': ['Drug: Vapendavir 132 mg capsules']}], 'interventions': [{'name': 'Vapendavir 300 mg tablet', 'type': 'DRUG', 'description': 'tablet - single dose', 'armGroupLabels': ['Vapendavir 300 mg tablet']}, {'name': 'Vapendavir 132 mg capsules', 'type': 'DRUG', 'description': '2 capsules - single dose', 'armGroupLabels': ['Two Vapendavir 132 mg capsules']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55101', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Investigative Site', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}], 'overallOfficials': [{'name': 'Mark Matson, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prism Research, Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biota Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}