Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 7:22 PM
Study NCT ID:
NCT01173757
Status:
COMPLETED
Last Update Posted:
2011-06-01
First Post:
2010-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-31', 'studyFirstSubmitDate': '2010-07-29', 'studyFirstSubmitQcDate': '2010-07-29', 'lastUpdatePostDateStruct': {'date': '2011-06-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Exposure response of overall 5HT4 receptor occupancy of PF-04995274', 'timeFrame': 'up to 3 days'}, {'measure': '5HT4 receptor occupancy by PF-04995274 at regions of interest within the human brain', 'timeFrame': 'up to 3 days'}], 'secondaryOutcomes': [{'measure': 'Adverse events', 'timeFrame': 'up to 3 days'}, {'measure': 'change from baseline in vital signs', 'timeFrame': 'up to 3 days'}, {'measure': 'Singlet ECG post-dose', 'timeFrame': 'up to 3 days'}, {'measure': 'Clinical safety laboratory endpoints', 'timeFrame': 'up to 3 days'}, {'measure': 'Clinical examinations', 'timeFrame': 'up to 3 days'}, {'measure': 'Cmax, Tmax, AUClast, and AUCinf for PF-04995274 in plasma', 'timeFrame': 'up to 3 days'}, {'measure': 'Cmax, Tmax, AUClast, and AUCinf for PF-05082547 in plasma', 'timeFrame': 'up to 3 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1661002&StudyName=To%20Evaluate%20The%20Relationship%20Between%20Plasma%20Drug%20Levels%20And%20Receptor%20Binding%20In%20Brain%20Using%20PET%20%28Positron%20Emission%20Tomography%29%20In%20He', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the relationship between plasma drug levels and receptor binding in brain using PET; and to evaluate safety and tolerability after a single administration of PF-04995274 in healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male and/or female subjects of nonchildbearing potential between the ages of 18 and 55 years, inclusive\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.\n* History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening\n* Fulfillment of any of the MRI contraindications on the standard radiography screening questionnaire'}, 'identificationModule': {'nctId': 'NCT01173757', 'briefTitle': 'To Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase I, Healthy Volunteer Determination Of 5HT4 Receptor Occupancy Of PF-04995274, Using PET With Ligand [11C]PF-05127401.', 'orgStudyIdInfo': {'id': 'B1661002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04995274', 'interventionNames': ['Drug: PF-04995274']}], 'interventions': [{'name': 'PF-04995274', 'type': 'DRUG', 'description': 'Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1', 'armGroupLabels': ['PF-04995274']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06520', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], '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.'}}}}