Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-04-26 @ 2:42 AM
Study NCT ID:
NCT02142920
Status:
COMPLETED
Last Update Posted:
2014-09-04
First Post:
2014-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C549060', 'term': 'gedatolisib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-02', 'studyFirstSubmitDate': '2014-05-13', 'studyFirstSubmitQcDate': '2014-05-16', 'lastUpdatePostDateStruct': {'date': '2014-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': '0.5 hours'}, {'measure': 'Time to Reach Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': '0.5 hours'}], 'secondaryOutcomes': [{'measure': 'Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)', 'timeFrame': '9 Days', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Area under the Concentration-Time Curve (AUC)', 'timeFrame': '9 days', 'description': 'AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.'}, {'measure': 'Plasma Decay Half-Life (t1/2)', 'timeFrame': '9 days', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Systemic Clearance (CL)', 'timeFrame': '9 days', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Volume of Distribution at Steady State (Vss)', 'timeFrame': '9 days', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '30256541', 'type': 'DERIVED', 'citation': 'Houk BE, Alvey CW, Visswanathan R, Kirkovsky L, Matschke KT, Kimoto E, Ryder T, Obach RS, Durairaj C. Distribution, Metabolism, and Excretion of Gedatolisib in Healthy Male Volunteers After a Single Intravenous Infusion. Clin Pharmacol Drug Dev. 2019 Jan;8(1):22-31. doi: 10.1002/cpdd.615. Epub 2018 Sep 26.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B2151006&StudyName=Investigation%20Of%20The%20Metabolism%2C%20And%20Excretion%20Of%20%5B14c%5D-PF-05212384%20In%20Healthy%20Male%20Volunteers%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to characterize how PF-05212384 is metabolized in the body following a single intravenous dose of radioactively labeled drug (\\[14C\\]-PF-05212384).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects between the ages of 30- 65 years vasectomised or \\>40 with no desire to father children in the near future (12 months), inclusive (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* Body Mass Index (BMI) of 17.5 to 35 kg/m2; and a total body weight \\>50 kg (110 lbs).\n* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.\n* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n* Subjects agree to use an adequate method of contraception\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 or history of drug or alcohol abuse in the past 2 years.'}, 'identificationModule': {'nctId': 'NCT02142920', 'briefTitle': 'Investigation Of The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'A Phase One, Open-Label Single-Radiolabeled Dose Study To Investigate The Metabolism, And Excretion Of [14c]-PF-05212384 In Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'B2151006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C] PF 05212384', 'description': 'Receive PF-05212384 89 mg Dose', 'interventionNames': ['Drug: PF-05212384']}], 'interventions': [{'name': 'PF-05212384', 'type': 'DRUG', 'description': 'Single 89 mg Dose via 30 minute IV infusion', 'armGroupLabels': ['[14C] PF 05212384']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington Fields', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Pfizer Investigational Site'}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}