Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-01-11 @ 2:53 PM
Study NCT ID:
NCT00627120
Status:
COMPLETED
Last Update Posted:
2009-01-09
First Post:
2008-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C518641', 'term': '3-phenyl-4,5-dihydro-5-isoxazole acetic acid'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'lastUpdateSubmitDate': '2009-01-08', 'studyFirstSubmitDate': '2008-01-17', 'studyFirstSubmitQcDate': '2008-02-20', 'lastUpdatePostDateStruct': {'date': '2009-01-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.', 'timeFrame': 'Day 8'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': 'Day 4'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.', 'detailedDescription': 'This study will evaluate:\n\n* The safety and tolerability of a single dose of VGX-1027 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs).\n* The pharmacokinetic (PK) profile of VGX-1027 maximum concentration (Cmax)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must give written informed consent.\n* Healthy subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations\n* Body Mass Index of 18-30kg/m\\^2 inclusive\n* Males or females ages 18-60, inclusive. Women who are not of childbearing potential may enroll. Women must have a negative pregnancy test within 72 hours prior to start of study drug administration or be surgically sterile.\n\nExclusion Criteria:\n\n* Women who are of childbearing potential\n* Women who are pregnant or breastfeeding\n* Women with a positive pregnancy test on enrollment or prior to study drug administration\n* Male subjects who are unwilling to agree to practice barrier contraception during the study and for three months following dosing\n* Any significant acute or chronic mental illness\n* Current or recent gastrointestinal disease that may impact the absorption of the drug\n* Any major surgery within 4 weeks of enrollment\n* Donation of blood or plasma to a blood bank or in a clinical study (except screening visit) within 4 weeks of enrollment\n* Blood transfusion within 4 weeks of enrollment\n* Inability to tolerate oral medication\n* Inability to be venipunctured and/or tolerate venous access\n* Recent (within 6 months) drug or alcohol abuse\n* History of bleeding disorder\n* History of head trauma or seizures\n* Any other sound medical, psychiatric and/or social reason as determined by the Investigator\n* Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determinations\n* Positive urine screen for drugs of abuse\n* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody\n* History of any significant drug allergy\n* Exposure to any investigational drug within 4 weeks prior to enrollment or greater that 4 weeks for investigational drugs that may have a longer half-life\n* Use of any prescription drugs or over the counter acid controllers within 4 weeks prior to enrollment\n* Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment\n* Use of oral, injectable or implantable hormonal contraceptive agents within 3 months prior to enrollment\n* Use of alcohol containing beverages within 1 week prior to enrollment\n* Use of grapefruit containing products within 1 week prior to enrollment\n* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g. infectious disease) illness must not be enrolled into this study.'}, 'identificationModule': {'nctId': 'NCT00627120', 'briefTitle': 'Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'VGX Pharmaceuticals, LLC'}, 'officialTitle': 'A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CAT001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': '1mg dose group', 'interventionNames': ['Drug: VGX-1027']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '10mg dose group', 'interventionNames': ['Drug: VGX-1027']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': '100mg dose group', 'interventionNames': ['Drug: VGX-1027']}, {'type': 'EXPERIMENTAL', 'label': '4', 'description': '200mg dose group', 'interventionNames': ['Drug: VGX-1027']}, {'type': 'EXPERIMENTAL', 'label': '5', 'description': '400mg dose group', 'interventionNames': ['Drug: VGX-1027']}, {'type': 'EXPERIMENTAL', 'label': '6', 'description': '800mg dose group', 'interventionNames': ['Drug: VGX-1027']}], 'interventions': [{'name': 'VGX-1027', 'type': 'DRUG', 'description': 'Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.', 'armGroupLabels': ['1', '2', '3', '4', '5', '6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'SNBL Clinical Pharmacology Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Stephan A Bart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SNBL Clinical Pharmacology Center, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VGX Pharmaceuticals, LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GeneOne Life Science, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'C. Jo White, MD', 'oldOrganization': 'VGX Pharmaceuticals, Inc'}}}}