Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01918202
Status:
COMPLETED
Last Update Posted:
2014-11-10
First Post:
2013-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545121', 'term': '2-((4-(1-methyl-4-pyridin-4-yl-1H-pyrazol-3-yl)phenoxy)methyl)quinoline'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-06', 'studyFirstSubmitDate': '2013-08-05', 'studyFirstSubmitQcDate': '2013-08-05', 'lastUpdatePostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Central PDE10A enzyme occupancy values in the striatum.', 'timeFrame': 'Day 10', 'description': 'Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, the central PDE10A enzyme occupancy values will be measured in the striatum at different single oral doses of PF-02545920.'}], 'secondaryOutcomes': [{'measure': 'Central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen (separately).', 'timeFrame': 'Day 10', 'description': 'Using Positron Emission Tomography and a radiotracer (MNI-659) for PF-02545920, central PDE10A enzyme occupancy values in the globus pallidus, in the caudate and in the putamen be measured (separately) at different single oral doses of PF-02545920.'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 10', 'description': 'Cmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Day 10', 'description': 'Tmax for serum PF-02545920 during the post-dose positron emission tomography (PET) scan.'}, {'measure': 'Average serum concentration', 'timeFrame': 'Day 10', 'description': 'Average serum 02545920 during the post-dose positron emission tomography (PET) scan.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Enzyme occupancy', 'PET', 'Phosphodiesterase 10 inhibitor'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '28122201', 'type': 'DERIVED', 'citation': 'Delnomdedieu M, Forsberg A, Ogden A, Fazio P, Yu CR, Stenkrona P, Duvvuri S, David W, Al-Tawil N, Vitolo OV, Amini N, Nag S, Halldin C, Varrone A. In vivo measurement of PDE10A enzyme occupancy by positron emission tomography (PET) following single oral dose administration of PF-02545920 in healthy male subjects. Neuropharmacology. 2017 May 1;117:171-181. doi: 10.1016/j.neuropharm.2017.01.016. Epub 2017 Jan 22.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A8241017&StudyName=A%20Study%20To%20Evaluate%20The%20PDE10%20Enzyme%20Occupancy%20Following%20A%20Single%20Dose%20Of%20PF-02545920%20In%20Healthy%20Male%20Volunteers', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This Phase 1 study will evaluate PDE10 enzyme occupancy using Positron Emission Tomography after a single dose of PF-02545920 in Healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy male volunteers\n\nExclusion Criteria:\n\n* History of orthostatic hypotension\n* History of prior radiation exposure for research purposes, or radiation therapy'}, 'identificationModule': {'nctId': 'NCT01918202', 'acronym': 'PET', 'briefTitle': 'A Study To Evaluate The PDE10 Enzyme Occupancy Following A Single Dose Of PF-02545920 In Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase 1, Open-label Adaptive Design Study To Evaluate Pde10 Enzyme Occupancy As Measured By Positron Emission Tomography (Pet) Following Single Oral Dose Administration Of Pf-02545920 In Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'A8241017'}, 'secondaryIdInfos': [{'id': '2013-002733-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1 - 20 mg', 'description': 'Cohort will include 4 HVs/completers who will receive a single 20 mg dose of PF-02545920.', 'interventionNames': ['Drug: 20 mg PF-02545920']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2 ( adaptive dose, optional)', 'description': 'Cohort 2 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.', 'interventionNames': ['Drug: PF-02545920']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3 ( adaptive dose, optional)', 'description': 'Cohort 3 will include 4 HVs/completers who will receive a single dose of PF-02545920. The dose will be selected based on the results obtained for Cohort 1.\n\nDose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg. This cohort is optional', 'interventionNames': ['Drug: PF-02545920']}], 'interventions': [{'name': '20 mg PF-02545920', 'type': 'DRUG', 'description': 'Subject will receive a single dose of 20 mg PF-02545920.', 'armGroupLabels': ['Cohort 1 - 20 mg']}, {'name': 'PF-02545920', 'type': 'DRUG', 'description': 'The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.\n\nThis cohort is optional.', 'armGroupLabels': ['Cohort 2 ( adaptive dose, optional)']}, {'name': 'PF-02545920', 'type': 'DRUG', 'description': 'The dose will be selected based on the results obtained for Cohort 1 and cohort 2.', 'armGroupLabels': ['Cohort 3 ( adaptive dose, optional)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE- 141 86', 'city': 'Huddinge', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Karolinska Trial Alliance (KTA) M62', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}