Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT01217918
Status:
COMPLETED
Last Update Posted:
2011-02-15
First Post:
2010-10-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-14', 'studyFirstSubmitDate': '2010-10-07', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2011-02-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adverse events; of clinical findings on physical examination; and of clinical laboratory abnormalities.', 'timeFrame': 'Day 1 to Follow-up'}, {'measure': 'Mean change from baseline in vital signs (blood pressure and heart rate) measurements', 'timeFrame': 'Baseline to Follow-up'}, {'measure': 'Mean change from baseline in 12-lead ECG parameters', 'timeFrame': 'Baseline to Follow-up'}, {'measure': 'Plasma PH-797804 Cmax, Cmin, Cavg(ss), Tmax, AUC(0-last), AUC(0-inf), AUC(0-tau), t1/2, CL/F, Vz/F, Rac, and Rac, Cmax', 'timeFrame': 'Days 1 and 10'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PH-797804', 'Japanese', 'Phase 1', 'multiple dose study'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631027&StudyName=Multiple%20Oral%20Doses%20Of%20PH-797804%20In%20Healthy%20Japanese%20Adult%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'Study A6631027 will evaluate the safety, tolerability and pharmacokinetics of PH-797804 when administered to healthy Japanese subjects once a day (QD) for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* Japanese\n\nExclusion Criteria:\n\n* Subjects with clinically significant skin lesions\n* Subjects with known tuberculosis infection'}, 'identificationModule': {'nctId': 'NCT01217918', 'briefTitle': 'Multiple Oral Doses Of PH-797804 In Healthy Japanese Adult Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'APhase 1, Placebo-Controlled, Randomized, Parallel Group, Subject- And Investigator-Blind, Sponsor-Open Study To Assess The Safety, Tolerability, And Pharmacokinetics Of PH-797804 Following Multiple Escalating Oral Doses In Healthy Japanese Adult Subjects', 'orgStudyIdInfo': {'id': 'A6631027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'PH-797804', 'interventionNames': ['Drug: 1 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'PH-797804', 'interventionNames': ['Drug: 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Cohotr 3', 'description': 'PH-797804', 'interventionNames': ['Drug: 10 mg']}], 'interventions': [{'name': '1 mg', 'type': 'DRUG', 'description': '1 mg or placebo a material sparing tablet per day for 10 days', 'armGroupLabels': ['Cohort 1']}, {'name': '5 mg', 'type': 'DRUG', 'description': '5 mg or placebo as material sparing tablet per day for 10 days', 'armGroupLabels': ['Cohort 2']}, {'name': '10 mg', 'type': 'DRUG', 'description': '10 mg or placebo as a material sparing tablet per day for 10 days', 'armGroupLabels': ['Cohotr 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90232', 'city': 'Culver City', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.02112, 'lon': -118.39647}}, {'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], '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.'}}}}