Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2025-12-26 @ 8:41 AM
Study NCT ID:
NCT01119235
Status:
COMPLETED
Last Update Posted:
2010-08-06
First Post:
2010-04-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-05', 'studyFirstSubmitDate': '2010-04-19', 'studyFirstSubmitQcDate': '2010-05-05', 'lastUpdatePostDateStruct': {'date': '2010-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentration of PF-04531083 in blood just before dosing on the 8th day of the study', 'timeFrame': 'Days 1 and 8 of the study'}], 'secondaryOutcomes': [{'measure': 'pharmacokinetic parameters derived from the plasma concentration versus time profile of PF-04531083 following single and multiple dosing. AUCtau, Cmax, Tmax will be calculated.', 'timeFrame': 'Days 1, 8 and 14 of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'tablet performance', 'healthy volunteers', 'open label'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1351005&StudyName=A%20Study%20To%20Observe%20The%20Performance%20Of%20A%20Tablet%20Form%20Of%20PF-04531083%20As%20Evidenced%20By%20The%20Concentration%20Of%20PF-04531083%20In%20The%20Blood%20W', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'A new tablet form of PF-04531083 has been manufactured. Previously the compound was administered as a solution/suspension to healthy volunteers. This study will investigate the pharmacokinetics of PF-044531083 in tablet form and compare with the pharmacokinetics obtained, with the same dosing regimen, with the solution/suspension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young\n* Healthy volunteers\n\nExclusion Criteria:\n\n* Elderly volunteers\n* Patients with any existing medical conditions considered likely to impinge on study execution'}, 'identificationModule': {'nctId': 'NCT01119235', 'briefTitle': 'A Study To Observe The Performance Of A Tablet Form Of PF-04531083 As Evidenced By The Concentration Of PF-04531083 In The Blood With Time Following Oral Administration To Healthy Volunteers.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open Label Study To Investigate The Pharmacokinetics Of Multiple Doses Of PF-04531083 Tablets In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B1351005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 1: PF-04531083', 'interventionNames': ['Drug: PF-04531083']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort 2: PF-04531083', 'interventionNames': ['Drug: PF-04531083']}], 'interventions': [{'name': 'PF-04531083', 'type': 'DRUG', 'description': 'Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days', 'armGroupLabels': ['Cohort 1: PF-04531083']}, {'name': 'PF-04531083', 'type': 'DRUG', 'description': 'Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1', 'armGroupLabels': ['Cohort 2: PF-04531083']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], '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.'}}}}