Ignite Creation Date:
2025-12-24 @ 3:57 PM
Ignite Modification Date:
2026-01-01 @ 7:10 AM
Study NCT ID:
NCT01234792
Status:
COMPLETED
Last Update Posted:
2012-07-10
First Post:
2010-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074164', 'term': 'Nicotine Chewing Gum'}], 'ancestors': [{'id': 'D002638', 'term': 'Chewing Gum'}, {'id': 'D053149', 'term': 'Plant Gums'}, {'id': 'D001704', 'term': 'Biopolymers'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002182', 'term': 'Candy'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-06', 'studyFirstSubmitDate': '2010-11-03', 'studyFirstSubmitQcDate': '2010-11-03', 'lastUpdatePostDateStruct': {'date': '2012-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'During 8 hours post-dose', 'description': 'Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)'}, {'measure': 'Area Under the Curve (AUC)(0-t)', 'timeFrame': 'During 8 hours post-dose', 'description': 'AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour \\* nanograms (ng) per milliliter (mL).'}, {'measure': 'AUC(0-∞)', 'timeFrame': '8 hours post-dose', 'description': 'AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smoking Cessation, Nicotine pharmacokinetics'], 'conditions': ['Tobacco Dependence']}, 'descriptionModule': {'briefSummary': 'Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.', 'detailedDescription': 'The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.\n* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.\n* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* Pregnancy, lactation or intended pregnancy.\n* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01234792', 'briefTitle': 'Single-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Johnson & Johnson Consumer and Personal Products Worldwide'}, 'officialTitle': 'Single-Dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products - A Study in Healthy Smokers', 'orgStudyIdInfo': {'id': 'NICTDP1070'}, 'secondaryIdInfos': [{'id': '2008-000596-15', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'NIC-6', 'description': '6 mg Experimental nicotine gum', 'interventionNames': ['Drug: 6 mg Experimental nicotine gum']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIC-4', 'description': '4 mg Nicotine Gum', 'interventionNames': ['Drug: 4 mg Nicotine Gum/']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NIC-2', 'description': '2 mg Nicotine Gum', 'interventionNames': ['Drug: 2 mg Nicotine Gum']}], 'interventions': [{'name': '6 mg Experimental nicotine gum', 'type': 'DRUG', 'otherNames': ['Not marketed'], 'description': 'A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits', 'armGroupLabels': ['NIC-6']}, {'name': '4 mg Nicotine Gum/', 'type': 'DRUG', 'otherNames': ['Nicorette® Gum'], 'description': 'A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits', 'armGroupLabels': ['NIC-4']}, {'name': '2 mg Nicotine Gum', 'type': 'DRUG', 'otherNames': ['Nicorette® Gum'], 'description': 'A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits', 'armGroupLabels': ['NIC-2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-222 20', 'city': 'Lund', 'country': 'Sweden', 'facility': 'McNeil AB Clinical Pharmacology R&D', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Elisabeth Kruse, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'McNeil AB'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McNeil AB', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}