Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT00772512
Status:
COMPLETED
Last Update Posted:
2010-03-19
First Post:
2008-10-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study Of The Effect Of PF-04802540 On Sleep Measures
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': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-04', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-03-17', 'studyFirstSubmitDate': '2008-10-13', 'studyFirstSubmitQcDate': '2008-10-13', 'lastUpdatePostDateStruct': {'date': '2010-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'REM sleep percentage', 'timeFrame': '1 day'}], 'secondaryOutcomes': [{'measure': 'REM sleep latency', 'timeFrame': '1 day'}, {'measure': 'Beta EEG power', 'timeFrame': '1 day'}, {'measure': 'Plasma concentrations of PF-04802540 and its metabolite, PF-04831035', 'timeFrame': '2 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PF-04802540, polysomnography, REM, cross over'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0911003&StudyName=A%20Study%20Of%20The%20Effect%20Of%20PF-04802540%20On%20Sleep%20Measures', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if PF-04802540 decreases REM sleep.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive\n* Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight \\>45 kg (99 lbs)\n* Non-users of nicotine\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant medical illness\n* A history of seizures, including childhood febrile seizures\n* Any condition possibly affecting drug absorption'}, 'identificationModule': {'nctId': 'NCT00772512', 'briefTitle': 'A Study Of The Effect Of PF-04802540 On Sleep Measures', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taisho Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Subject- And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 3-Way Crossover Study To Study Effects Of PF-04802540 On Polysomnography Endpoints In Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B0911003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: PF-04802540']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: PF-04802540']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'C', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04802540', 'type': 'DRUG', 'description': '5 mg capsule, single dose', 'armGroupLabels': ['A']}, {'name': 'PF-04802540', 'type': 'DRUG', 'description': '15 mg capsule, single dose', 'armGroupLabels': ['B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo capsule, single dose', 'armGroupLabels': ['C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10019', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taisho Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldOrganization': 'Taisho Pharmaceutical Co., Ltd.'}}}}