Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-26 @ 5:21 AM
Study NCT ID:
NCT00452894
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2007-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012907', 'term': 'Smoking'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068580', 'term': 'Varenicline'}], 'ancestors': [{'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011810', 'term': 'Quinoxalines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-03-28', 'studyFirstSubmitDate': '2007-03-26', 'studyFirstSubmitQcDate': '2007-03-27', 'lastUpdatePostDateStruct': {'date': '2008-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PK parameters after a single dose and PK parameters after 7 days of multiple dosing respectively.'}], 'secondaryOutcomes': [{'measure': 'To gather safety data from Day 0 to Day 17 of the study.'}]}, 'conditionsModule': {'conditions': ['Smoking']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A3051076&StudyName=Phase+1+Clinical+Trial+of+Varenicline+in+Chinese+Healthy+Smoking+Volunteers+', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "This study is to measure how much of varenicline tartrate is in Chinese healthy smokers' blood and urine after taking a single dose and several doses respectively, and also to test the safety (the impact of the study drug on Chinese healthy smokers' body) of varenicline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female Chinese subjects between the ages of 18 and 45 years, inclusive.\n* Body Mass Index (BMI) of approximately 19 to 24 kg/m2; and a total body weight ≥50 kg.\n* Individuals who have smoked an average of at least 10 cigarettes per day during the past year, with no period of abstinence greater than 3 months in the past year.\n\nExclusion Criteria:\n\n* Heart rate\\>100 bpm, QRS Interval\\>120 msec, QTc Interval \\>430 msec, PR Interval\\>220 msec, or any other abnormalities observed on the Electrocardiogram.\n* Subjects with a sitting blood pressure of 140/90 mmHg or above at screening.\n* Subjects with evidence or history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric or neurological disease, or any condition possibly affecting drug absorption.'}, 'identificationModule': {'nctId': 'NCT00452894', 'briefTitle': 'Phase 1 Clinical Trial of Varenicline in Chinese Healthy Smoking Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Pharmacokinetic, Toleration And Safety Study Of Single And Multiple Oral Doses Of Varenicline In Chinese Healthy Volunteers', 'orgStudyIdInfo': {'id': 'A3051076'}}, 'armsInterventionsModule': {'interventions': [{'name': 'varenicline tartrate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}}}}