Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2025-12-27 @ 11:04 PM
Study NCT ID:
NCT01527734
Status:
COMPLETED
Last Update Posted:
2012-02-08
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013779', 'term': 'Tetrodotoxin'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008387', 'term': 'Marine Toxins'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'lastUpdateSubmitDate': '2012-02-07', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-02-06', 'lastUpdatePostDateStruct': {'date': '2012-02-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare plasma and urine PK profiles of TTX following doses of Lyophilized and Injectable Liquid TTX', 'timeFrame': '26 timepoints over 48 hours', 'description': 'PK timepoints occurred at 0,0.33,0.67,1, 1.5,2,4,6,8,10,12,14 and 24 hours after first dose on Days 1 \\& 2. Liquid and Lyophilized formulations will be assessed using ANOVA of the T-R ratio based on log-transformed AUC and Cmax values.'}], 'secondaryOutcomes': [{'measure': 'Assess the safety and tolerability of TTX following the administration of Lyophilized and Liquid TTX', 'timeFrame': 'signage of the ICF to Day 10', 'description': "Safety was assessed through the collection of AE's, concomitant medications, clinical laboratory assessments, neurological assessments and vital signs. Where summary statistics are presented, these will include n, mean, standard deviation, median, minimum, and maximum."}]}, 'conditionsModule': {'keywords': ['Comparison study'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.wextech.ca/', 'label': 'Sponsor website'}]}, 'descriptionModule': {'briefSummary': 'The study design is a randomized, double-blind, placebo-controlled, parallel-group, dose comparison with a open-label, crossover, formulation comparison.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Normal renal function\n\nExclusion Criteria:\n\n* History of multiple clinically significant drug allergies'}, 'identificationModule': {'nctId': 'NCT01527734', 'briefTitle': 'Comparison Study of Liquid and Lyophilized Formulations of Subcutaneous Tetrodotoxin (TTX) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wex Pharmaceuticals Inc.'}, 'officialTitle': 'COMPARISON OF THE PHARMACOKINETICS AND SAFETY OF LIQUID (30 µg) AND LYOPHILIZED TETRODOTOXIN (15 µg AND 30 µg) FOLLOWING SINGLE AND TWICE DAILY SUBCUTANEOUS DOSE ADMINISTRATION TO HEALTHY VOLUNTEERS-DETERMINATIONS IN BLOOD AND URINE', 'orgStudyIdInfo': {'id': 'TTX-CINP-201PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Tetrodotoxin, TTX', 'interventionNames': ['Drug: Tetrodotoxin']}], 'interventions': [{'name': 'Tetrodotoxin', 'type': 'DRUG', 'description': '15ug and 30ug once or twice a day for 1 or 2 days.', 'armGroupLabels': ['Tetrodotoxin, TTX']}, {'name': 'placebo', 'type': 'DRUG', 'description': '1ml once or twice a day for 1 or 2 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98418', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Comprehensive Clinical Research', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wex Pharmaceuticals Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}