Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-23 @ 3:01 PM
Study NCT ID:
NCT01986660
Status:
COMPLETED
Last Update Posted:
2014-01-27
First Post:
2013-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-23', 'studyFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2013-11-11', 'lastUpdatePostDateStruct': {'date': '2014-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax, Tmax, Trough Concentrations Days 2 to 8, AUC 0-24, Steady State, T1/2', 'timeFrame': '9 days'}], 'secondaryOutcomes': [{'measure': 'Clinical laboratory change from baseline', 'timeFrame': '14 days'}, {'measure': 'Modified Berger Bowman Skin Assessment', 'timeFrame': '14 days'}, {'measure': 'Vital Signs', 'timeFrame': '14 days'}, {'measure': 'Adverse Events', 'timeFrame': '14 days'}]}, 'conditionsModule': {'keywords': ['Pharmacokinetic Study'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate how Ibuprofen Cream (SST-0225) is absorbed and eliminated by the body under defined maximum dosing conditions and to evaluate the safety under these conditions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed consent form\n* Men, women, 18 to 55 years\n* Females must not be pregnant or plan to become pregnant\n* BMI 18 to 30 kg/m2\n* Past or non-smoker\n* High probability of compliance with completion of study\n* Healthy as determined by investigator based on medical history, physical exam, clinical laboratory tests, vital sign measurements, ECGs\n\nExclusion Criteria:\n\n* Presence or history of disorder that could interfere with completion of study\n* Unstable medical condition\n* Surgical or medical condition that may interfere with absorption, distribution, metabolism or excretion of test drug\n* Positive Hep B, Hep C and/or HIV test\n* Positive urine drug screen\n* Any history of skin disorders, including psoriasis, eczema, tattoos, significant scarring, healing wounds, skin lesions on knees or elbows\n* Significant disease\n* Any clinically important deviation from normal limits in physical exam, vital sign measurements, 12 lead ECG, clinical laboratory test\n* History of drug abuse with 1 year\n* History of alcoholism with 1 year\n* Use of prescription medications or ibuprofen within 30 days of Day 1, use of OTC drugs, herbal supplements and vitamins within 14 days of Day 1.\n* Use of investigational drug within 30 day of Day 1\n* Acute disease state within 7 days of Day 1\n* Consumption of grapefruit or grapefruit containing products within 72 hours of Day 1\n* Tobacco use/caffeine use within 48 hours of Day 1'}, 'identificationModule': {'nctId': 'NCT01986660', 'briefTitle': 'Open-Label, Maximum-Dose Pharmacokinetic Study of 7.5% Ibuprofen Cream (SST-0225) in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Strategic Science & Technologies, LLC'}, 'orgStudyIdInfo': {'id': 'SST0225-US-011-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ibuprofen Cream (SST-0225)', 'interventionNames': ['Drug: Ibuprofen Cream (SST-0225)']}], 'interventions': [{'name': 'Ibuprofen Cream (SST-0225)', 'type': 'DRUG', 'armGroupLabels': ['Ibuprofen Cream (SST-0225)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'SST Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Strategic Science & Technologies, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}