Ignite Creation Date:
2025-12-24 @ 6:32 PM
Ignite Modification Date:
2025-12-29 @ 2:51 PM
Study NCT ID:
NCT01602757
Status:
COMPLETED
Last Update Posted:
2012-10-17
First Post:
2012-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic Study of Synera in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D013748', 'term': 'Tetracaine'}, {'id': 'D057968', 'term': 'Transdermal Patch'}], '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': 'D062366', 'term': 'para-Aminobenzoates'}, {'id': 'D062365', 'term': 'Aminobenzoates'}, {'id': 'D001565', 'term': 'Benzoates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-15', 'studyFirstSubmitDate': '2012-05-15', 'studyFirstSubmitQcDate': '2012-05-17', 'lastUpdatePostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Peak plasma concentration (Cmax) of Synera after application of 4 patches', 'timeFrame': '0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose', 'description': 'Peak plasma concentration of Synera after application of 4 patches for 2-, 4- and 12-hours'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': '24 days'}, {'measure': 'Area under the plasma concentration versus time (AUC) of Synera', 'timeFrame': '0.5, 1, 1.5, 2, 4, 8, 10, 12 hours post-dose', 'description': 'Area under the plasma concentration versus time curve of Synera after application of 4 patches for 2-, 4-, and 12 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '22943969', 'type': 'RESULT', 'citation': 'Marriott TB, Charney MR, Stanworth S. Effects of application durations and heat on the pharmacokinetic properties of drug delivered by a lidocaine/tetracaine patch: a randomized, open-label, controlled study in healthy volunteers. Clin Ther. 2012 Oct;34(10):2174-83. doi: 10.1016/j.clinthera.2012.08.008. Epub 2012 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'This study will measure the amount of lidocaine and tetracaine in the blood after 2-, 4-, and 12-hour application of 4 Synera patches and a 4 hour application of 4 patches without heat.', 'detailedDescription': 'The purpose of this study was to evaluate the pharmacokinetic profiles of lidocaine and tetracaine after 2-, 4-, and 12-hour application of 4 Synera® patches and a 4-hour application of 4 lidocaine/tetracaine patches without heat in healthy adult subjects and to monitor the frequency and nature of adverse events. In addition to determining the pharmacokinetics for a one-time application of 4 Synera® patches, steady-state pharmacokinetics were modeled and residual patch concentrations of lidocaine and tetracaine were determined.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be at least 18 years of age\n* be a nonsmoker\n* have a body mass index (BMI) ≥ 18.5 and \\< 30.0\n\nExclusion Criteria:\n\n* known or suspected hypersensitivity, allergies, or other contraindications to any compound present in the study drug, including lidocaine, tetracaine, or other local anesthetics.\n* have a defect, injury or a dermatological disease or condition in the skin area where the study drug was to be applied.\n* have a history or current evidence of any hepatic impairment.\n* have failed the urine drug screen.\n* have used or been administered a local or systemic anesthetic, including over-the-counter products, within the past 14 days.\n* have donated blood or plasma within the past 30 days.\n* have participated in a clinical research study within the past 30 days.\n* are pregnant, breastfeeding, or was a female of childbearing potential and not practicing adequate birth control'}, 'identificationModule': {'nctId': 'NCT01602757', 'briefTitle': 'Pharmacokinetic Study of Synera in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'ZARS Pharma Inc.'}, 'officialTitle': 'An Open-Label Pharmacokinetic Study of the Synera Patch Applied for 2-, 4-, and 12-hours and a Lidocaine/Tetracaine Patch Without Heat Applied for 4 Hours in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'SC-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Synera', 'description': 'Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat ("no heat patches") and were crossed over during Study Session 3.', 'interventionNames': ['Drug: Synera']}], 'interventions': [{'name': 'Synera', 'type': 'DRUG', 'otherNames': ['Lidocaine 70 mg/Tetracaine 70 mg topical patch'], 'description': 'Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat ("no heat patches") and were crossed over during Study Session 3.', 'armGroupLabels': ['Synera']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58104', 'city': 'Fargo', 'state': 'North Dakota', 'country': 'United States', 'facility': 'Cetero Research', 'geoPoint': {'lat': 46.87719, 'lon': -96.7898}}], 'overallOfficials': [{'name': 'Anthony R Godfrey, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cetero Research, San Antonio'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ZARS Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}