Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT00774605
Status:
COMPLETED
Last Update Posted:
2009-01-26
First Post:
2008-10-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-22', 'studyFirstSubmitDate': '2008-10-16', 'studyFirstSubmitQcDate': '2008-10-16', 'lastUpdatePostDateStruct': {'date': '2009-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Varenicline area under the curve from 0 to the last quantifiable concentration (AUClast) and varenicline area under the curve from 0 to infinity (AUCinf)', 'timeFrame': '8 days'}], 'secondaryOutcomes': [{'measure': 'Evaluation of adverse events (including skin irritation)', 'timeFrame': '8 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['percutaneous, transcutaneous, topical, varenicline, transdermal, transdermal delivery system, patch'], 'conditions': ['Smoking Cessation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051118&StudyName=A%20Study%20Evaluating%20The%20Absorption%20Of%20Varenicline%20Into%20The%20Body%20From%20A%20Varenicline%20Solution%20And%20A%20Varenicline%20Patch%20Applied%20To%20The%20Sk', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the absorption, safety, and tolerability of a varenicline solution and a varenicline patch applied to the skin.', 'detailedDescription': 'Additional Study Purpose Details: Evaluation of the pharmacokinetic profile of a varenicline solution and a varenicline patch applied to the skin'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy, adult, male smokers\n\nExclusion Criteria:\n\n* significant medical illness'}, 'identificationModule': {'nctId': 'NCT00774605', 'briefTitle': 'A Study Evaluating The Absorption Of Varenicline Into The Body From A Varenicline Solution And A Varenicline Patch Applied To The Skin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-Label, Nonrandomized, Single Dose Study To Characterize The Pharmacokinetics Of A Varenicline (CP-526,555) Transdermal Solution And A Varenicline Transdermal Delivery System Applied To The Skin Of Adult Smokers', 'orgStudyIdInfo': {'id': 'A3051118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varenicline free base solution', 'interventionNames': ['Drug: Varenicline free base solution']}, {'type': 'EXPERIMENTAL', 'label': 'Varenicline transdermal delivery system', 'interventionNames': ['Drug: Varenicline free base patch']}], 'interventions': [{'name': 'Varenicline free base solution', 'type': 'DRUG', 'description': 'A single application of a 4.8 mg varenicline solution will be applied to the upper back over a 24 hour period', 'armGroupLabels': ['Varenicline free base solution']}, {'name': 'Varenicline free base patch', 'type': 'DRUG', 'description': 'A single application of a nominal 1.2 mg dose of a varenicline transdermal delivery system (5 cm2 patch, 4.8 mg drug payload) will be applied to the upper back over a 24 hour period', 'armGroupLabels': ['Varenicline transdermal delivery system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc.'}}}}