Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-02-20 @ 6:25 PM
Study NCT ID:
NCT01298505
Status:
TERMINATED
Last Update Posted:
2019-02-11
First Post:
2011-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C569673', 'term': '3-fluoro-3-(3-fluoro-4-(pyrrolidin-1-ylmethyl)phenyl)-N-(2-methylpropyl)cyclobutanecarboxamide'}, {'id': 'C093230', 'term': 'fexofenadine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'This study was stopped due to lack of evidence for clinical efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2010-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-07', 'studyFirstSubmitDate': '2011-02-02', 'studyFirstSubmitQcDate': '2011-02-16', 'lastUpdatePostDateStruct': {'date': '2019-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse events as a measure of safety and tolerability.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of PF-03654764 will be measured.', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase 1 multiple dose safety toleration fexofenadine'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0711006&StudyName=A%20Study%20To%20Investigate%20The%20Safety%20And%20Toleration%20Of%20Multiple%20Oral%20Doses%20Of%20PF-03654764%20In%20Combination%20With%20Fexofenadine%20In%20Healthy%20Sub', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study in heathy people is to investigate the safety, toleration and time course of PF-03654764 in the blood, following multiple doses given by mouth together with fexofenadine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).\n* A positive urine drug screen.\n* Treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication.'}, 'identificationModule': {'nctId': 'NCT01298505', 'briefTitle': 'A Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of PF-03654764 In Combination With Fexofenadine In Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1 Double-blind (3rd Party Open), Randomized, Placebo-controlled Study To Investigate The Safety And Toleration Of Multiple Oral Doses Of Pf-03654764 In Combination With Fexofenadine In Healthy Subjects', 'orgStudyIdInfo': {'id': 'B0711006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-03654764 2.5mg plus fexofenadine 60mg', 'interventionNames': ['Drug: PF-03654764 2.5mg plus fexofenadine 60mg']}, {'type': 'EXPERIMENTAL', 'label': 'PF-03654764 5mg plus fexofenadine 60mg', 'interventionNames': ['Drug: PF-03654764 5mg plus fexofenadine 60mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'PF-03654764 2.5mg plus fexofenadine 60mg', 'type': 'DRUG', 'description': 'PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days', 'armGroupLabels': ['PF-03654764 2.5mg plus fexofenadine 60mg']}, {'name': 'PF-03654764 5mg plus fexofenadine 60mg', 'type': 'DRUG', 'description': 'PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days', 'armGroupLabels': ['PF-03654764 5mg plus fexofenadine 60mg']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo given twice daily for 7 days', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '188770', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Pfizer Clinical Research Unit', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}