Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-24 @ 3:22 PM
Study NCT ID:
NCT04144192
Status:
COMPLETED
Last Update Posted:
2024-05-23
First Post:
2019-10-28
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D057968', 'term': 'Transdermal Patch'}, {'id': 'C511998', 'term': 'Lidoderm'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2014-07-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-22', 'studyFirstSubmitDate': '2019-10-28', 'studyFirstSubmitQcDate': '2019-10-28', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax) of lidocaine', 'timeFrame': '0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose', 'description': 'Peak plasma concentration of lidocaine after application of 3 patches for 12 hours'}, {'measure': 'Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time 48 hours', 'timeFrame': '0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose', 'description': 'Area under the plasma concentration versus time curve from 0 to 48 hours of lidocaine in plasma'}, {'measure': 'Area under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time Infinity', 'timeFrame': '0, 2, 4, 6, 9, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 48 hours post-dose', 'description': 'Area under the plasma concentration versus time curve from 0 to infinite time of lidocaine in plasma'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '32606914', 'type': 'DERIVED', 'citation': 'Gudin J, Argoff C, Fudin J, Greuber E, Vought K, Patel K, Nalamachu S. A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects. J Pain Res. 2020 Jun 22;13:1485-1496. doi: 10.2147/JPR.S237934. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to characterize the comparative single-dose pharmacokinetics (bioequivalence) of lidocaine patch 1.8% (investigational product) versus Lidoderm® (lidocaine patch 5%,reference product).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be healthy based on by medical history, laboratory work, and physical exam\n* Be at least 18 years of age to 65 years of age\n* If childbearing potential, use of acceptable form of birth control\n* In the case of females of childbearing potential, have a negative serum pregnancy test\n\nExclusion Criteria:\n\n* Use of a prescription medication within 14 days or over-the-counter products within 7 days prior to administration of study medication\n* Known hypersensitivity or allergy to any of the components of the lidocaine topical system formulation\n* Any serious illness in the 4 weeks preceding the beginning of treatment that resulted in missed work or hospitalization'}, 'identificationModule': {'nctId': 'NCT04144192', 'briefTitle': 'Pharmacokinetic Study of Lidocaine Patch 1.8% Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Scilex Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase 1, Randomized, Comparative Pharmacokinetic Study of Bolus Intravenous Lidocaine 0.7 mg/kg, Lidocaine Patch 1.8%, and Lidocaine Patch 5% (Lidoderm®) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'SCI-LIDO-PK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lidocaine Patch (Sequence AB)', 'description': 'Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 1, 3 lidocaine 1.8% patches were applied on Day 8 and 3 Lidoderm® 5% patches were applied on Day 15.', 'interventionNames': ['Drug: Lidocaine patch 1.8%', 'Drug: Lidocaine 5% patch', 'Drug: Lidocaine 2% Injectable Solution']}, {'type': 'EXPERIMENTAL', 'label': 'Lidocaine Patch (Sequence BA)', 'description': 'Subjects received all study treatments: a bolus IV injection of 0.7 mg/kg lidocaine IV in the morning of study Day 1, and then lidocaine patch treatment on Day 8 and Day 15. The sequence in which they received patch treatment was determined by random assignment. For subjects in Arm 2, 3 Lidoderm® 5% patches were applied on Day 8 and 3 lidocaine 1.8% patches were applied on Day 15.', 'interventionNames': ['Drug: Lidocaine patch 1.8%', 'Drug: Lidocaine 5% patch', 'Drug: Lidocaine 2% Injectable Solution']}], 'interventions': [{'name': 'Lidocaine patch 1.8%', 'type': 'DRUG', 'otherNames': ['Lidocaine topical system 1.8%'], 'armGroupLabels': ['Lidocaine Patch (Sequence AB)', 'Lidocaine Patch (Sequence BA)']}, {'name': 'Lidocaine 5% patch', 'type': 'DRUG', 'otherNames': ['Lidoderm'], 'armGroupLabels': ['Lidocaine Patch (Sequence AB)', 'Lidocaine Patch (Sequence BA)']}, {'name': 'Lidocaine 2% Injectable Solution', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine Patch (Sequence AB)', 'Lidocaine Patch (Sequence BA)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Phillip LaStella, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TKL Research, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Scilex Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}