Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2026-02-25 @ 5:35 PM
Study NCT ID:
NCT02089295
Status:
COMPLETED
Last Update Posted:
2016-04-04
First Post:
2014-03-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010098', 'term': 'Oxycodone'}], 'ancestors': [{'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-31', 'studyFirstSubmitDate': '2014-03-13', 'studyFirstSubmitQcDate': '2014-03-13', 'lastUpdatePostDateStruct': {'date': '2016-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48', 'description': 'AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Concentration at time 24 hours (C24)', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '0,0.5,1,2,3,4,5,6,8,10,12,16,24,36,48', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dose proportionality', 'oxycodone'], 'conditions': ['Healthy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B4501035&StudyName=Dose%20Proportionality%20Study%20Of%20PF-00345439%20Formulation%20Under%20Fed%20Conditions', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of PF 00345439 formulation under fed conditions 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 between 18 and 55 years of age\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant disease.\n* Positive urine drug test'}, 'identificationModule': {'nctId': 'NCT02089295', 'briefTitle': 'Dose Proportionality Study Of PF-00345439 Formulation Under Fed Conditions', 'organization': {'class': 'UNKNOWN', 'fullName': 'PainT'}, 'officialTitle': 'An Open-label, Randomized, Single-dose, Three-way Crossover Study to Evaluate the Dose Proportionality of 5 Mg, 20 Mg and 40 Mg of PF-00345439 Formulation K Under Intermediate-fat Fed Conditions in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'B4501035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'Single dose of 5 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'Single dose of 20 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).', 'interventionNames': ['Drug: Oxycodone']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).', 'interventionNames': ['Drug: Oxycodone']}], 'interventions': [{'name': 'Oxycodone', 'type': 'DRUG', 'description': 'One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions', 'armGroupLabels': ['Treatment A']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions', 'armGroupLabels': ['Treatment B']}, {'name': 'Oxycodone', 'type': 'DRUG', 'description': 'One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions', 'armGroupLabels': ['Treatment C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66211', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pain Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}